Reported Jun 1, 2016 · Terminated
Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
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?
- Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
- Lot codes and dates
- Part #'s HAA60-11030 HAA60-13030 HAA60-15040 HAA60-16040 HAA60-18040 Lot #'s
016150016210165130016230133890181600133970134000181620
- Part #'s HAA60-11030 HAA60-13030 HAA60-15040 HAA60-16040 HAA60-18040 Lot #'s
- Amount recalled
- N/A
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
- Nationwide
Why it was recalled
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
This product could cause temporary or reversible health problems — stop using it.
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