Reported Aug 28, 2013 · Terminated
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with…
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?
- Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
- Lot codes and dates
193 of 193 codes
25621400203600257116002038002562130025621500203700206500266010006002554725003900600164856002803760028040600280416002804260016492600280456001648760028036600280386002803960028043600343296003433060039203600382456004314660039161600391706003917325209700600391846003918660039201600392076001649160028044600392146003921760039218600392206003922260039223600392246003432860039158600391996003921622390036503636503436503760016497600392216004314760039166600391686003918260039183
- Amount recalled
- 1,710 units are in distribution
This recall covers 48 products
The agency filed one notice per product. You are reading one of them; the other 47 are below.
35 more are in the archive.
Where it was sold
Why it was recalled
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single 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 single packaging tray configuration, which
This product could cause temporary or reversible health problems — stop using it.
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