Home / Recalls / Medical Devices
Novapproach Spine LLC recalls OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneL
Recalled November 23, 2022 · FDA recall Z-0246-2023 · Novapproach Spine
Hazard
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. · FDA Class II
Units
6 devices
Sold at
US Nationwide distribution in the states of CA and NY.
Description
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
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.
Manufacturer(s)
Novapproach Spine LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →