Reported Nov 20, 2013 · Terminated
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems.…
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?
- VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
- Lot codes and dates
858 of 858 codes
003696730036989800369984003699850036998800369989003699950036999600369997003699980037007400370082003701030037016100370162003701630037016500370166003702400037024100370242003702440037024500370246003702850037029900370300003703010037037100370374003703760037037700370378003703790037038200370405003704060037040700370409003704110037041700370428003704710037047500370620003706210037090660486158604957996049580160545572605455736054557460565682605656836058939260589393605893946060987060609871
- Amount recalled
- 12866 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid
This product could cause temporary or reversible health problems — stop using it.
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