Device product
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Z-0866-2021
Product summary
- Event
- Event 85133
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0866-2021
Official wording
Reason: A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Code information: OsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957
Distribution pattern: U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Derived failure modes
-
Unknown
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.