FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0867-2021
- Recalling firm
- Skeletal Kinetics, Llc
- 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.
- Status
- Terminated
- Initiated
- 2019-06-06
- Posted
- not on file
- Terminated
- 2024-09-18
- 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 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
- 49 units
- Distribution
- U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
- Lot, serial or model codes
- OsteoVation, Inject, 10cc (part number 390-2010, manufacturing lot 1130303, label no 12464). UDI (2): (01) 0 0813845 02006 1 (17) 210501 (10) 1130303
- 510(k) numbers
- ["K051784"]
- PMA numbers
- not on file
- Product code
- GXP
- Firm FEI
- 3003890476
- Firm city
- Addison
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28