Reported Oct 15, 2014 · Terminated
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint…
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 · 46581
Is this the product you have?
- Compress Face Reamer Product UsageCorrection of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma
- Lot codes and dates
- Catalog numbers32-481000
- Lot Numbers
615860765230
- Catalog Number32-481001
- Lot Number Identification
121450392410765250974290
- Amount recalled
- 4
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Investigation determined that units supplied were missing the 4x21 degree helix angle.
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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