FDAOctober 12, 2022device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.

What to do

FDA enforcement status: Terminated

Brands named

novapproach spinenovapproach

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 Details · AllClear