FDA Medical Device Recalls (openFDA)
Novapproach Spine LLC: 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.
- Recall number
- Z-0246-2023
- Recalling firm
- Novapproach Spine LLC
- 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.
- Status
- Terminated
- Initiated
- 2022-10-12
- Posted
- 2022-11-17
- Terminated
- 2026-04-01
- Reason
- The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 6 devices
- Distribution
- US Nationwide distribution in the states of CA and NY.
- Lot, serial or model codes
- Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
- 510(k) numbers
- ["K211769"]
- PMA numbers
- not on file
- Product code
- OVD
- Firm FEI
- 3020307303
- Firm city
- Alachua
- Firm state
- FL
- 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