Skeletal Kinetics, Llc Recall 85133
Description: 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.
Skeletal Kinetics, Llc Recall 85133 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0866-2021 |
| Event ID | 85133 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution including in the states of TX, NY, FL and AZ. |
| Quantity | 2 units |
| Recall 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. |
| Device Classification | 20210127 |
| Device Code Info | OsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957 |
| Center Classification Date | 20210115 |
| Recall Initiation Date | 20190606 |
| Recalling Firm | Skeletal Kinetics, Llc |
| Initial Notification | Letter |
| Similar To |