Reported Feb 7, 2024 · Ongoing
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Howmedica Osteonics Corp.
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: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement
- Product Number6637-4-031
- Lot codes and dates
- GTIN04546540306920
- Lot Numbers
3627360136609701
This recall covers 58 products
The agency filed one notice per product. You are reading one of them; the other 57 are below.
45 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
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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