Recall Z-0867-2021 ยท GXP Methyl Methacrylate For Cranioplasty
Skeletal Kinetics, Llc
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.
| Date | Jun 6, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | On June 7, 2019, customers were notified by letter sent by FedEx that Skeletal Kinetics LLC (Skeletal Kinetics) is voluntarily recalling certain OsteoVation, Inject Bone Void Filler kits distributed by OsteoMed LLC.The recall was initiated to correct a discrepancy between the Mixing Instruction Card and the Instructions for Use. The letter notes that Skeletal Kinetics has not received any customer complaints or reports of injury to the patient or end user. Customers are requested to: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Rece |
| Quantity | 49 units |
| Distribution | U.S. Nationwide distribution including in the states of TX, NY, FL and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051784 | OSTEOVATION CMF BONE VOID FILLER Skeletal Kinetics, LLC, Jul 20, 2005 |