Z-0867-2021 Class II Terminated
FDA device recall Z-0867-2021 was initiated by Skeletal Kinetics, Llc on June 6, 2019 and is designated Class II. 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. The recall status is terminated (terminated September 18, 2024). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- June 6, 2019
- Termination Date
- September 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product 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 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.
Distribution Pattern
U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
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