Reported Nov 6, 2013 · Terminated
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
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?
- Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
- Lot codes and dates
- Part Number Range00-8770-040-01/05 & 01.01062.405/408
- Amount recalled
- 194 (8770-040)
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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