Reported Jan 8, 2014 · Terminated
DIST LAT FEM LOCK PLT, LT
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. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- DIST LAT FEM LOCK PLT, LT
- Lot codes and dates
- Item Number47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023
- Amount recalled
- 42, 065 units total
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Why it was recalled
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
This product could cause temporary or reversible health problems — stop using it.
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