Howmedica Osteonics Corp. 2024-02-07 Health serious FDA
Health · FDA · Recall #FDA-Z-0914-2024
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number:… Recall
Issued February 7, 2024 · Howmedica Osteonics Corp.
In February 2024, Howmedica Osteonics Corp. recalled the PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Howmedica Osteonics Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Howmedica Osteonics Corp.
- Category
- Health
- Recall date
- February 7, 2024
- Units affected
- Not reported
- Sold at
- Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden
- Recall number
- FDA-Z-0914-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Howmedica Osteonics Corp. has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.