Reported Jun 1, 2016 · Terminated
PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
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?
- PerFuse Decompression Instrument PN800-0541
- Lot100650. Designed to access the femoral head for decompression
- Lot codes and dates
- PerFuse Decompression Instrument PN800-0541
- Lot100650
- Amount recalled
- 22
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.
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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