Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product Recalled by Osteomed, LLC Due to Incorrect shelf-life for bone void filler kits; the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Osteomed, LLC directly.
Affected Products
OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Quantity: 300
Why Was This Recalled?
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Osteomed, LLC
Osteomed, LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report