FDA Enforcement
Class II
Terminated
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: Z-0867-2021
·
Reported January 27, 2021
Enforcement
- Recall Number
- Z-0867-2021
- Event ID
- 85133
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Skeletal Kinetics, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 27, 2021
- Initiation Date
- June 6, 2019
- Classification Date
- January 15, 2021
- Termination Date
- September 18, 2024
- Address
- 3885 Arapaho Rd, N/A, Addison, TX, 75001-4314, United States
Description
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.
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.
Code Info
OsteoVation, Inject, 10cc (part number 390-2010, manufacturing lot 1130303, label no 12464). UDI (2): (01) 0 0813845 02006 1 (17) 210501 (10) 1130303
Distribution
U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Quantity
49 units