OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Hazard
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
What You Should Do
Remedy
On 04/02/2020, an URGENT Medical Device Recall letter was sent to all consignees affected by the recall. OsteoMed has requested that affected customers: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax; and (2) return unused inventory via Federal Express (using OsteMed account)
Affected by this recall?
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Products
OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Brand
- Osteomed, LLC
- UPC
- LOT 1135741, 1130301, 1127941
Units Affected
70