Reported Mar 4, 2015 · Terminated
Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and…
Zimmer GmbH
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 Gmbh · Sulzer Allee 8 · Winterthur, N/A · N/A
Is this the product you have?
- Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.
- Lot codes and dates
- Item numbers
265 of 265 codes
00-8775-028-0100-8775-028-0200-8775-028-0300-8775-032-0100-8775-032-0200-8775-032-0300-8775-032-0400-8775-036-0100-8775-036-0200-8775-036-0300-8775-036-0400-8775-040-0100-8775-040-0200-8775-040-0300-8775-040-04. Lot #'s: 2524205252752925318172543976254703025227132535758254160525442632538145254161325242412524242253575625357572538147253818425439782543979254957225538882557023255937225241992524200252753525275362527537253203825357592535765253576625381482538149253815225381862545261254698025482302551239255487525570332524204252753825275392538153
- Item numbers
- Amount recalled
- 10340
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
This product could cause temporary or reversible health problems — stop using it.
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