Recall Z-0246-2023
Novapproach Spine LLC · initiated October 12, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
Codes / lots: Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
Reason for recall
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recalling firm issued letters dated 10/10/2022 via email on 10/12/2022. The email briefly described the product to be recalled, the issue, and what the consignee needed to do. The letter, which was also mailed to the consignee via certified mail, return receipt, on 10/12/2022, describes the product, reason for recall, and provides the actions necessary to complete the product removal. The actions include immediately discontinuing use of the torque adapter, remove it from the consigned OneLIF INS-Instrument Kits(s), receive a replacement OneLIF Torque adapter Lot 106607 to add back to the kit, and receive a return label to return the torque adapter to the location provided. No response form was enclosed. The recalling firm will be coordinating with a third-party logistics provider to track the return of the product for quarantine and storage until all product has been returned.
Details
- Recall number
- Z-0246-2023
- Initiated
- October 12, 2022
- Posted by FDA
- November 17, 2022
- Terminated
- April 1, 2026
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Quantity
- 6 devices
- Distribution
- US Nationwide distribution in the states of CA and NY.
- Recalling firm
- Novapproach Spine LLC, Alachua, FL