Valorem Surgical LLC: Devices are not consistent with Quality System Requirements.

Agency Publication Date: August 10, 2017

Affected Products

Product: PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1007. Unknown Lot No.

Product: PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. C060-050; Known Lot No. WNV110516

Product: PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. C060-060; Known Lot No. WNV110516

Product: PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. CL060-100; Lot No. Unknown.

Product: PALLAS M/MAXIMIS Small Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. CL47-000; Known Lot No. NHS160219.

Product: PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. CL60-100; Known Lot No. NHS160219.

Product: PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. CR60-030; Lot No. Unknown.

Product: PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. CR60-035; Lot No. Unknown.

Product: PALLAS M/MAXIMIS MIS Poly Screw Driver B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. Unknown; Known Lot No. NHS160315.

Product: PALLAS M/MAXIMIS 30mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-030; Lot No. Unknown.

Product: PALLAS M/MAXIMIS 35mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-035; Known Lot No. WNV110428 & Unknown.

Product: PALLAS M/MAXIMIS 40mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-040; Known Lot No. WNV120322 & Unknown.

Product: PALLAS M/MAXIMIS 45mm MIS . Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-045; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-050; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-060; Known Lot No. WNV120322 & Unknown.

Product: PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-070; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 80mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. M058-080; Known Lot No. WNV111019 & WNV120424.

Product: PALLAS M/MAXIMIS 40mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. MR58-040; Known Lot No. NHS150817.

Product: PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. MR58-035; Known Lot No. NHS150611 & WNV120323.

Product: PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. MR58-045; Known Lot No. WNV110128.

Catalog No. MR58-050; Known Lot No. WNV101020.

Product: PALLAS M/MAXIMIS 55mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. MR58-055; Known Lot No. NHS160219.

Catalog No. MR58-060; Known Lot No. NHS150611 & NHS160219.

Product: PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. MR58-080; Known Lot No. WNV120424.

Product: PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. N009-000; Known Lot No. NHS160219, NHS151030, WNV120323, WNV110427, WNV101206, WNV120320, WNV120321, NHS150813.

Product: PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P355-030; Known Lot No. WNV120322

Product: PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P355-050; Known Lot No. WNV110513.

Product: PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P355-040; Known Lot No. WNV110511.

Product: PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P365-045; Known Lot No. WNV110513.

Product: PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P365-050; Known Lot No. WNV110513.

Product: PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P365-055; Lot No. WNV120322.

Product: PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P375-040; Known Lot No. WNV120328 & WNV110525.

Product: PALLAS M/MAXIMIS Poly Screw 7.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P375-045; Known Lot No. WNV120328.

Product: PALLAS M/MAXIMIS Poly Screw 7.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P375-050; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS Poly Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P375-055; Known Lot No. WNV120322.

Catalog No. P755-030; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P755-035; Known Lot No. WNV120322 WNV120413.

Product: PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P755-040; Known Lot No. Unknown, WNV110513, WNV120322, WNV110511.

Product: PALLAS M/MAXIMIS Polyaxial and MIS Screw, 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P755-045; Known Lot No. WNV110511, WNV120413, WNV120322, WNV120427, WNV130510.

Product: PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P755-050; Known Lot No. WNV110513 and Unknown

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P765-035; Known Lot No. WNV110513, WNV120420.

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P765-040; Known Lot No. WNV120322, WNV110512, WNV120427, WNV120413.

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P765-045; Known Lot No. Unknown, WNV120420, WNV120322, NHS150153, WNV120427, WNV120430.

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P765-050; Known Lot No.Unknown, WNV110513, WNV120430, WNV120540, WNV120322, WNV120372.

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P765-055; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS MIS Screw 7.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P775-035; Known Lot No. WNV110525.

Product: PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P775-040; Known Lot No. WNV110513.

Product: PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P775-045; Known Lot No. Unknown, WNV120328, WNV120430, WNV110513.

Product: PALLAS M/MAXIMIS 7.5 x 50mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM775-050; Known Lot No. Unknown, WNV120328, WNV120322.

Product: PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. P775-055; Known Lot No. WNV120322, WNV120328.

Product: PALLAS M/MAXIMIS MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM755-045; Known Lot No. Unknown, WNV130510, WNV120275, NHS160219, NHS170323, NHS150813.

Product: PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM755-050; Known Lot No. Unknown, NHS160219, NHS150813, WNV110513, WNV120322.

Product: PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM755-055; Known Lot No. NHS160219.

Catalog No. PM765-035; Known Lot No. Unknown.

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM765-040; Known Lot No. Unknown, NHS150813, WNV120322.

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM765-045; Known Lot No. NHS160219, NHS150813, WNV120322.

Catalog No. PM765-050; Known Lot No. Unknown, NHS160219, WNV120322.

Product: PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM765-055; Known Lot No. Unknown, NHS160219.

Catalog No. PS355-035; Known Lot No. WNV101201.

Product: PALLAS M/MAXIMIS Poly Screw 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PS355-040; Known Lot No. NHS150813, WNV101201.

Product: PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PS355-055; Known Lot No. NHS160219.

Product: PALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PS355-045; Known Lot No. NHS150813, WNV101201.

Product: PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PS365-035; Known Lot No. WNV101206.

Catalog No. PS365-040; Known Lot No. NHS150813, WNV101213.

Catalog No. PS365-045; Known Lot No. NHS150813, WNV101206.

Catalog No. PS365-050; Known Lot No. NHS160219, NHS101206, WNV101206.

Product: PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. R060-030; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. R060-035 and R060-040; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS MIS Screw 5.5 x 40mm and 5.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. PM755-040; Known Lot No. NHS150813, WNV110513, WNV12064.

Product: PALLAS M/MAXIMIS 45mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. R060-045; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. R060-050; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 60mm Curved and Precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. R060-060; Known Lot No. WNV120323, WNV120420.

Product: PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. R060-070; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 80mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. R060-080; Known Lot No. WNV120322.

Product: PALLAS M/MAXIMIS 35mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-035; Known Lot No. NHS100106.

Product: PALLAS M/MAXIMIS 40mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-040; Known Lot No. WNV101022.

Product: PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-045; Known Lot No. WNV101015.

Product: PALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-050; Known Lot No. WNV100426.

Product: PALLAS M/MAXIMIS 60mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-060; Known Lot No. WNV101109, WNV120322.

Product: PALLAS M/MAXIMIS 70mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-070; Known Lot No. WNV101110.

Product: PALLAS M/MAXIMIS 80mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-080; Known Lot No. WNV100210.

Product: PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. S060-250; Known Lot No. WNV111123.

Product: PALLAS M/MAXIMIS 35mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. SR60-035; Known Lot No. NHS100106.

Product: PALLAS M/MAXIMIS 300mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. SR60-300; Known Lot No. NHS160219.

Product: PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. SR60-040; Known Lot No. WNV120328, WNV101022.

Product: PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. SR60-350; Known Lot No. NHS160219.

Product: PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. SR60-400; Known Lot No. NHS160219.

Product: PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. SR60-500; Known Lot No. NHS160219.

Product: PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0001; Known Lot No. WNV101126.

Product: PALLAS M/MAXIMIS Tapper 5.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0004; Known Lot No. WNV111130.

Product: PALLAS M/MAXIMIS Tapper 6.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0005; Known Lot No. WNV111130.

Product: PALLAS M/MAXIMIS Wall Check. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0007; Known Lot No. WNV111115.

Product: PALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0010; Known Lot No. WNV111116.

Product: PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0011; Known Lot No. WNV111118, WNV120321..

Product: PALLAS M/MAXIMIS Rod Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0012; Known Lot No. WNV101203, WNV111130.

Product: PALLAS M/MAXIMIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0014; Known Lot No. WNV110216.

Product: PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0015; Known Lot No. WNV111105.

Product: PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0016; Known Lot No. WNV100630.

Product: PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0017; Known Lot No. WNV100630.

Product: PALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0018; no known Lot No.

Product: PALLAS M/MAXIMIS Marking Pin (Round Jaw). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0019; no known Lot No.

Product: PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0021; Known Lot No. WNV111130.

Product: PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0027; Known Lot No. WNV111118.

Product: PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0028; Known Lot No. WNV110406, WNV110307.

Product: PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0703-0030; Known Lot No. WNV111109.

Product: PALLAS M/MAXIMIS Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1002; Known Lot No. WNV120802.

Product: PALLAS M/MAXIMIS Dilator A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1003; Known Lot No. WNV111108, WNV120802, WNV111109.

Product: PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1004; Known Lot No. WNV120814, WNV111109.

Product: PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1005; Known Lot No. WNV120320, WNV110826.

Product: PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1007; Known Lot No. WNV120817, NHS170405.

Product: PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1008; Known Lot No. WNV120320, WNV110830, NHS170405.

Product: PALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1009; Known Lot No. WNV120820, WNV110727.

Product: PALLAS M/MAXIMIS Open Extension (Large). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1010; Known Lot No. WNV120820, WNV101022.

Product: PALLAS M/MAXIMIS Closed Extension. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1012; Known Lot No. WNV120820, WNV110821, WNV110311, WNV120914.

Product: PALLAS M/MAXIMIS Extension Block. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1015; Known Lot No. WNV120723, WNV110331.

Product: PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1016; Known Lot No. WNV120814, WNV110322.

Product: PALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1017; Known Lot No. WNV120822, WNV110318.

Product: PALLAS M/MAXIMIS Extension Sleeve. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1018; Known Lot No. WNV120806, WNV110322.

Product: PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1019; Known Lot No. WNV120816, WNV111108.

Product: PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1020. Known Lot No. WNV111108, WNV120424.

Product: PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1021. Known Lot No. WNV111108, WNV120802.

Product: PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1023. Known Lot No. WNV111118, WNV110819, WNV110720, WNV110725, WNV120802.

Catalog No. 0902-1025. Known Lot No. WNV120802.

Product: PALLAS M/MAXIMIS Rod Checker. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1026. Known Lot No. WNV100705.

Product: PALLAS M/MAXIMIS Rod Gauge. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1027. Known Lot No. WNV120723.

Product: PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1028. Known Lot No. WNV101222, WNV120802, WNV120611, WNV111109.

Product: PALLAS M/MAXIMIS MIS Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1029. Known Lot No. WNV120328.

Product: PALLAS M/MAXIMIS Rod Checker and T-Bar. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1030. Known Lot No. WNV120802, WNV100705.

Product: PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1032. Known Lot No. WNV100705, WNV120802.

Product: PALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1033. Known Lot No. WNV120810, WNV111109.

Product: PALLAS M/MAXIMIS Ratchet T Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1036. Known Lot No. WNV111125, WNV111109, WNV120518, WNV120320.

Product: PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1037. Known Lot No. WNV111125, WNV120802, WNV111109.

Product: PALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1039. Known Lot No. WNV120810, WNV110520.

Product: PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Catalog No. 0902-1040. Known Lot No. WNV120817, WNV110830, NHS170405.

Product: PALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. WNV110826.

Product: PALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. WNV110318, WNV120809.

Product: PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. WNV111118.

Product: PALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. WNV111118.

Product: PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. NHS160315.

Product: PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. WNV111014.

Product: PALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. NHS170410.

Product: PALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. NHS170405.

Product: PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. NHS160219

Product: PALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Instrument, Known Lot No. WNV11116

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77500

Status: Resolved

Manufacturer: Valorem Surgical LLC

Manufactured In: United States

Units Affected: 143 products (2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 2,225 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total; 262 units total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Catalog No. 0902-1007. Unknown Lot No.

Catalog No. C060-050; Known Lot No. WNV110516

Catalog No. C060-060; Known Lot No. WNV110516

Catalog No. CL060-100; Lot No. Unknown.

Catalog No. CL47-000; Known Lot No. NHS160219.

Catalog No. CL60-100; Known Lot No. NHS160219.

Catalog No. CR60-030; Lot No. Unknown.

Catalog No. CR60-035; Lot No. Unknown.

Catalog No. Unknown; Known Lot No. NHS160315.

Catalog No. M058-030; Lot No. Unknown.

Catalog No. M058-035; Known Lot No. WNV110428 & Unknown.

Catalog No. M058-040; Known Lot No. WNV120322 & Unknown.

Catalog No. M058-045; Known Lot No. WNV120322.

Catalog No. M058-050; Known Lot No. WNV120322.

Catalog No. M058-060; Known Lot No. WNV120322 & Unknown.

Catalog No. M058-070; Known Lot No. WNV120322.

Catalog No. M058-080; Known Lot No. WNV111019 & WNV120424.

Catalog No. MR58-040; Known Lot No. NHS150817.

Catalog No. MR58-035; Known Lot No. NHS150611 & WNV120323.

Catalog No. MR58-045; Known Lot No. WNV110128.

Catalog No. MR58-050; Known Lot No. WNV101020.

Catalog No. MR58-055; Known Lot No. NHS160219.

Catalog No. MR58-060; Known Lot No. NHS150611 & NHS160219.

Catalog No. MR58-080; Known Lot No. WNV120424.

Catalog No. N009-000; Known Lot No. NHS160219, NHS151030, WNV120323, WNV110427, WNV101206, WNV120320, WNV120321, NHS150813.

Catalog No. P355-030; Known Lot No. WNV120322

Catalog No. P355-050; Known Lot No. WNV110513.

Catalog No. P355-040; Known Lot No. WNV110511.

Catalog No. P365-045; Known Lot No. WNV110513.

Catalog No. P365-050; Known Lot No. WNV110513.

Catalog No. P365-055; Lot No. WNV120322.

Catalog No. P375-040; Known Lot No. WNV120328 & WNV110525.

Catalog No. P375-045; Known Lot No. WNV120328.

Catalog No. P375-050; Known Lot No. WNV120322.

Catalog No. P375-055; Known Lot No. WNV120322.

Catalog No. P755-030; Known Lot No. WNV120322.

Catalog No. P755-035; Known Lot No. WNV120322 WNV120413.

Catalog No. P755-040; Known Lot No. Unknown, WNV110513, WNV120322, WNV110511.

Catalog No. P755-045; Known Lot No. WNV110511, WNV120413, WNV120322, WNV120427, WNV130510.

Catalog No. P755-050; Known Lot No. WNV110513 and Unknown

Catalog No. P765-035; Known Lot No. WNV110513, WNV120420.

Catalog No. P765-040; Known Lot No. WNV120322, WNV110512, WNV120427, WNV120413.

Catalog No. P765-045; Known Lot No. Unknown, WNV120420, WNV120322, NHS150153, WNV120427, WNV120430.

Catalog No. P765-050; Known Lot No.Unknown, WNV110513, WNV120430, WNV120540, WNV120322, WNV120372.

Catalog No. P765-055; Known Lot No. WNV120322.

Catalog No. P775-035; Known Lot No. WNV110525.

Catalog No. P775-040; Known Lot No. WNV110513.

Catalog No. P775-045; Known Lot No. Unknown, WNV120328, WNV120430, WNV110513.

Catalog No. PM775-050; Known Lot No. Unknown, WNV120328, WNV120322.

Catalog No. P775-055; Known Lot No. WNV120322, WNV120328.

Catalog No. PM755-045; Known Lot No. Unknown, WNV130510, WNV120275, NHS160219, NHS170323, NHS150813.

Catalog No. PM755-050; Known Lot No. Unknown, NHS160219, NHS150813, WNV110513, WNV120322.

Catalog No. PM755-055; Known Lot No. NHS160219.

Catalog No. PM765-035; Known Lot No. Unknown.

Catalog No. PM765-040; Known Lot No. Unknown, NHS150813, WNV120322.

Catalog No. PM765-045; Known Lot No. NHS160219, NHS150813, WNV120322.

Catalog No. PM765-050; Known Lot No. Unknown, NHS160219, WNV120322.

Catalog No. PM765-055; Known Lot No. Unknown, NHS160219.

Catalog No. PS355-035; Known Lot No. WNV101201.

Catalog No. PS355-040; Known Lot No. NHS150813, WNV101201.

Catalog No. PS355-055; Known Lot No. NHS160219.

Catalog No. PS355-045; Known Lot No. NHS150813, WNV101201.

Catalog No. PS365-035; Known Lot No. WNV101206.

Catalog No. PS365-040; Known Lot No. NHS150813, WNV101213.

Catalog No. PS365-045; Known Lot No. NHS150813, WNV101206.

Catalog No. PS365-050; Known Lot No. NHS160219, NHS101206, WNV101206.

Catalog No. R060-030; Known Lot No. WNV120322.

Catalog No. R060-035 and R060-040; Known Lot No. WNV120322.

Catalog No. PM755-040; Known Lot No. NHS150813, WNV110513, WNV12064.

Catalog No. R060-045; Known Lot No. WNV120322.

Catalog No. R060-050; Known Lot No. WNV120322.

Catalog No. R060-060; Known Lot No. WNV120323, WNV120420.

Catalog No. R060-070; Known Lot No. WNV120322.

Catalog No. R060-080; Known Lot No. WNV120322.

Catalog No. S060-035; Known Lot No. NHS100106.

Catalog No. S060-040; Known Lot No. WNV101022.

Catalog No. S060-045; Known Lot No. WNV101015.

Catalog No. S060-050; Known Lot No. WNV100426.

Catalog No. S060-060; Known Lot No. WNV101109, WNV120322.

Catalog No. S060-070; Known Lot No. WNV101110.

Catalog No. S060-080; Known Lot No. WNV100210.

Catalog No. S060-250; Known Lot No. WNV111123.

Catalog No. SR60-035; Known Lot No. NHS100106.

Catalog No. SR60-300; Known Lot No. NHS160219.

Catalog No. SR60-040; Known Lot No. WNV120328, WNV101022.

Catalog No. SR60-350; Known Lot No. NHS160219.

Catalog No. SR60-400; Known Lot No. NHS160219.

Catalog No. SR60-500; Known Lot No. NHS160219.

Catalog No. 0703-0001; Known Lot No. WNV101126.

Catalog No. 0703-0004; Known Lot No. WNV111130.

Catalog No. 0703-0005; Known Lot No. WNV111130.

Catalog No. 0703-0007; Known Lot No. WNV111115.

Catalog No. 0703-0010; Known Lot No. WNV111116.

Catalog No. 0703-0011; Known Lot No. WNV111118, WNV120321..

Catalog No. 0703-0012; Known Lot No. WNV101203, WNV111130.

Catalog No. 0703-0014; Known Lot No. WNV110216.

Catalog No. 0703-0015; Known Lot No. WNV111105.

Catalog No. 0703-0016; Known Lot No. WNV100630.

Catalog No. 0703-0017; Known Lot No. WNV100630.

Catalog No. 0703-0018; no known Lot No.

Catalog No. 0703-0019; no known Lot No.

Catalog No. 0703-0021; Known Lot No. WNV111130.

Catalog No. 0703-0027; Known Lot No. WNV111118.

Catalog No. 0703-0028; Known Lot No. WNV110406, WNV110307.

Catalog No. 0703-0030; Known Lot No. WNV111109.

Catalog No. 0902-1002; Known Lot No. WNV120802.

Catalog No. 0902-1003; Known Lot No. WNV111108, WNV120802, WNV111109.

Catalog No. 0902-1004; Known Lot No. WNV120814, WNV111109.

Catalog No. 0902-1005; Known Lot No. WNV120320, WNV110826.

Catalog No. 0902-1007; Known Lot No. WNV120817, NHS170405.

Catalog No. 0902-1008; Known Lot No. WNV120320, WNV110830, NHS170405.

Catalog No. 0902-1009; Known Lot No. WNV120820, WNV110727.

Catalog No. 0902-1010; Known Lot No. WNV120820, WNV101022.

Catalog No. 0902-1012; Known Lot No. WNV120820, WNV110821, WNV110311, WNV120914.

Catalog No. 0902-1015; Known Lot No. WNV120723, WNV110331.

Catalog No. 0902-1016; Known Lot No. WNV120814, WNV110322.

Catalog No. 0902-1017; Known Lot No. WNV120822, WNV110318.

Catalog No. 0902-1018; Known Lot No. WNV120806, WNV110322.

Catalog No. 0902-1019; Known Lot No. WNV120816, WNV111108.

Catalog No. 0902-1020. Known Lot No. WNV111108, WNV120424.

Catalog No. 0902-1021. Known Lot No. WNV111108, WNV120802.

Catalog No. 0902-1023. Known Lot No. WNV111118, WNV110819, WNV110720, WNV110725, WNV120802.

Catalog No. 0902-1025. Known Lot No. WNV120802.

Catalog No. 0902-1026. Known Lot No. WNV100705.

Catalog No. 0902-1027. Known Lot No. WNV120723.

Catalog No. 0902-1028. Known Lot No. WNV101222, WNV120802, WNV120611, WNV111109.

Catalog No. 0902-1029. Known Lot No. WNV120328.

Catalog No. 0902-1030. Known Lot No. WNV120802, WNV100705.

Catalog No. 0902-1032. Known Lot No. WNV100705, WNV120802.

Catalog No. 0902-1033. Known Lot No. WNV120810, WNV111109.

Catalog No. 0902-1036. Known Lot No. WNV111125, WNV111109, WNV120518, WNV120320.

Catalog No. 0902-1037. Known Lot No. WNV111125, WNV120802, WNV111109.

Catalog No. 0902-1039. Known Lot No. WNV120810, WNV110520.

Catalog No. 0902-1040. Known Lot No. WNV120817, WNV110830, NHS170405.

Instrument, Known Lot No. WNV110826.

Instrument, Known Lot No. WNV110318, WNV120809.

Instrument, Known Lot No. WNV111118.

Instrument, Known Lot No. NHS160315.

Instrument, Known Lot No. WNV111014.

Instrument, Known Lot No. NHS170410.

Instrument, Known Lot No. NHS170405.

Instrument, Known Lot No. NHS160219

Instrument, Known Lot No. WNV11116

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77500

Status: Resolved

Manufacturer: Valorem Surgical LLC

Manufactured In: United States