Device product
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Z-0867-2021
Product summary
- Event
- Event 85133
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-0867-2021
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, 10cc (part number 390-2010, manufacturing lot 1130303, label no 12464). UDI (2): (01) 0 0813845 02006 1 (17) 210501 (10) 1130303
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.