Reported Nov 23, 2022 · Terminated
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine…
Novapproach Spine LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novapproach Spine LLC · 13900 Tech City Cir Ste 300 · Alachua, FL · 32615-6091
Is this the product you have?
- 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.
- Lot codes and dates
Torque adapter - Lot #104713UDI G07001501000000Kit IDs - 504505506501101and 105
- Amount recalled
- 6 devices
Where it was sold
Why it was recalled
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
This product could cause temporary or reversible health problems — stop using it.
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