CLASS II Device recall · Reported 23 Nov 2022 · FDA Enforcement Report
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 25Nm Limit recalled
Novapproach Spine is recalling OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 25Nm Limit, distributed nationwide in the US. The recall was initiated on 12 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0246-2023
- FDA event ID
- 91016
- Recalling firm
- Novapproach Spine, Alachua, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2022
- FDA classified
- 17 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 12 Oct 2022 | Recall initiated by company | |
| 17 Nov 2022 | Classified by FDA | +36 days |
| 23 Nov 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of CA and NY.
Questions about this recall
Is OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 25Nm Limit recalled?
Yes. Novapproach Spine recalled OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 25Nm Limit on 12 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0246-2023.
Why was it recalled?
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Which lots are affected?
Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
Where was it sold?
US Nationwide distribution in the states of CA and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novapproach Spine
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OneLIF Interbody Cage recalled by Novapproach Spine | Novapproach Spine | Lead & Heavy Metals | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |