Z-0246-2023Class II

OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach...

Name: Z-0246-2023 OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach...
Creator: Novapproach Spine LLC
Published: 2022-10-12
License: https://open.fda.gov/license/

Novapproach Spine LLC / initiated 2022-10-12 / Terminated / root cause: manufacturing process

FDA source

Novapproach Spine LLC began a recall of 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... on 2022-10-12. FDA classified it as Class II and gives the reason as "The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0246-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-12
Posted: 2022-11-17
Terminated: 2026-04-01
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.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Root cause tag: manufacturing process
FDA 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 in commerce: 6 devices
Distribution: US Nationwide distribution in the states of CA and NY.
Product codes and lots: Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0246-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0246-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-23	2022-11-17

Product code OVD

K211769Class IIOneLIF Intervertebral Body Replacement SystemNovapproach Spine / cleared 2021-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)