Home / Recalls / Zimmer, Inc. / Z-0007-2023

Z-0007-2023 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
October 12, 2022
Initiation Date
August 25, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
56 US

Product Description

G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty

Reason for Recall

The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

Distribution Pattern

Domestic distribution US nationwide.

Code Information

Item No. 010000663 UDI-DI: 00880304524224 Lots: 7286477 7289929 7296576 7296633 7301697 Exp. 21-Jul-32 Item No. 010000667 UDI-DI: 00880304524262 Lot: 7253325 Exp. 13-Jun-32

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