Reported Jun 12, 2013 · Terminated
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Biomet, 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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
- Lot codes and dates
- Part numbers
EP-200162EP-200162EP-200164
- and EP-200166 with Lot numbers
027050101470115950101480247990948810967270027070287820729870and 860880
- Part numbers
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.
This product could cause temporary or reversible health problems — stop using it.
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