Home / Recalls / Zimmer Biomet, Inc. / Z-1306-2018

Z-1306-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
April 11, 2018
Initiation Date
October 25, 2017
Termination Date
May 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22

Product Description

A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403

Reason for Recall

The drill guides were manufactured with the incorrect color anodization.

Distribution Pattern

Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.

Code Information

Package Lot: 989430; Lot Etched on Product: P0284

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  • Z-0333-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutr (September 24, 2020)
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  • Z-0327-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut (September 24, 2020)
  • Z-0379-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d (September 24, 2020)
  • Z-0341-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut (September 24, 2020)
  • Z-0385-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (September 24, 2020)