Stryker Spine: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

Agency Publication Date: November 19, 2012

Affected Products

Product: Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench i

Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655

Lot Numbers:

Number

Product: Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench

Class I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400

Lot Numbers:

Number

Product: SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicato

Class I device, 510(K) exempt Catalog Number: IS2217XLP Lot Number: 2576, 2756

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63386

Status: Resolved

Manufacturer: Stryker Spine

Manufactured In: United States

Units Affected: 3 products (54; 19 units; 28 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655

Lot Numbers:

Number

Class I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400

Lot Numbers:

Number

Class I device, 510(K) exempt Catalog Number: IS2217XLP Lot Number: 2576, 2756

Lot Numbers:

Number