Skeletal Kinetics, Llc 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 Receipt Form via email or the enclosed pre-paid envelope; and (2) return unused inventory via Federal Express with reference to Return Material Authorization FER 3003890476-6/6/19-001-R or by pickup by the sales representative indicated on the Acknowledgement and Receipt Form. Customers with questions are instructed to contact Mr. Randy Mosley, Director of QA, Skeletal Kinetics LLC by telephone at 972 677 4789 Monday-Friday, 8 AM 5 PM CDT.