Reported Jun 10, 2020 · Terminated
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - 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?
- OSTEOVATIONEX 3CC INJECT FORMULA
- REF/UDI390-0003/00813845020016 -
- Product UsageThe product provides a bone void filler that is replaced by bone during the healing process
- Lot codes and dates
LOT 1710040211279421130302113574011420701142943
- Amount recalled
- 270
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.
Free recall alerts
Get alerted about new Osteomed, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.