FDA recall Z-0246-2023

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.

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA and NY.

Key facts

Status

Terminated

Initiation date

2022-10-12

Report date

2022-11-23

Termination date

2026-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alachua, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0246-2023