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.

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.

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.