Class 2 Device Recall OsteoVation, Inject

• Date Initiated by Firm: June 06, 2019
• Create Date: January 15, 2021
• Recall Status: Terminated on September 18, 2024
• Recall Number: Z-0867-2021
• Recall Event ID: 85133
• 510(K)Number: K051784
• Product Classification: Methyl methacrylate for cranioplasty - Product Code GXP
• 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.
• 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
• Recalling Firm/ Manufacturer: Skeletal Kinetics, Llc; 3885 Arapaho Rd; Addison TX 75001-4314
• For Additional Information Contact: Randy Nosley; 972-677-4602
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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.
• Quantity in Commerce: 49 units
• Distribution: U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GXP