Reported Jun 10, 2020 · Terminated
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void…
Osteomed, LLC
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: Osteomed, LLC · 3885 Arapaho Rd · Addison, TX · 75001-4314
Is this the product you have?
- OSTEOVATION 5CC IMPACTFORMULA
- REF/UDI390-2105/00813845020085 -
- Product UsageThe product provides a bone void filler that is replaced by bone during the healing process
- Lot codes and dates
LOT 1706050917102710170405331705191111269861128789113423211363301144043 and 1142210
- Amount recalled
- 1724
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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