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U.S. Department of Health and Human Services

Class 2 Device Recall OsteoVation, Inject, Bone Void Filler

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 Class 2 Device Recall OsteoVation, Inject, Bone Void Fillersee related information
Date Initiated by FirmJune 06, 2019
Create DateJanuary 15, 2021
Recall Status1 Terminated 3 on September 18, 2024
Recall NumberZ-0866-2021
Recall Event ID 85133
510(K)NumberK051784 
Product Classification Methyl methacrylate for cranioplasty - Product Code GXP
ProductOsteoVation, 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.
Code Information OsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) .  UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957   
Recalling Firm/
Manufacturer		 Skeletal Kinetics, Llc
3885 Arapaho Rd
Addison TX 75001-4314
For Additional Information ContactRandy 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 2		Labeling Change Control
ActionOn 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 Commerce2 units
DistributionU.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GXP
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