Reported Oct 12, 2022 · Ongoing
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- G7 Acetabular System, Acetabular Shell
- Item numbers Item Numbers010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
- Lot codes and dates
- Item No. 010000663
- UDI-DI00880304524224
- Lots7286477 7289929 7296576 7296633 7301697 Exp. 21-Jul-32 Item No. 010000667
- UDI-DI00880304524262
- Lot7253325 Exp. 13-Jun-32
- Amount recalled
- 56 US
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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