Reported Feb 26, 2014 · Terminated
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
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?
2 of 2 products · 3 lot codes
| Product number | Lot codes and dates |
|---|---|
12 |
|
12 |
|
- Lot codes and dates
3,264 of 3,264 codes
36536536566460095144601062946010629560106296601096966010969760124944601249456013452060134521601383816013838260157045601570466015704760173107601735576017849360189233601905446019679960205060602050626021571760232508602325716023668060238555602391706023917260239173602499466025002260250024602626966026270360274914602749156027491660275490602754916027549260346324603463256034907660349077603490786034907960349080603891186039270660425077604311576043116060431161604584716046670460475849
- Amount recalled
- 7,044,680 total
This recall covers 44 products
The agency filed one notice per product. You are reading one of them; the other 43 are below.
31 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
This product could cause temporary or reversible health problems — stop using it.
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