Reported Jul 22, 2015 · Terminated
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
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?
- A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
- Lot codes and dates
- Part number856135060
- Lot061300
- Amount recalled
- 50 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
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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