Reported Nov 2, 2016 · Terminated
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Zimmer 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: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
- Lot codes and dates
- Item Number 00-5927-040-00 Serial Number All
- Amount recalled
- 703
Where it was sold
- Nationwide
Why it was recalled
Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery
This product could cause temporary or reversible health problems — stop using it.
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