Exactech, Inc.: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Agency Publication Date: June 2, 2016

Affected Products

Product: Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021

Lot Numbers:

MRA

Product: Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

Product Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.

Lot Numbers:

MRA

Product: Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-00-13, Serial Numbers: 4333544, 4333545, 4333546, Exp.3/22/2021 and Serial Number 4335281, Exp. 3/23/2021.

Product: Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-00-14, Serial Number: 4252802, Exp. 1/25/2021.

Product: Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-10-16, Serial Number: 4256338, Exp. 1/27/2021.

Product: Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-30-11, Serial Numbers: 4273184, 4273185, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 and 4273186, Exp. 2/8/2021.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73200

Status: Resolved

Manufacturer: Exactech, Inc.

Manufactured In: United States

Units Affected: 6 products (3 devices; 2 devices.; 4 devices.; 1 device.; 1 device.; 9 devices.)

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Sources: FDA iRES · Raw API Response

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