Reported Mar 4, 2015 · Terminated
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of…
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?
- Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
- Lot codes and dates
- Item numbers
19.32.0519.32.0619.32.08Lot #'s: 25605852553420255603925605862563398
- Item numbers
- Amount recalled
- 30
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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