Novapproach Spine LLC: Medical Device Recall in 2022 - (Recall #: Z-0246-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 12, 2022

Date Posted: November 23, 2022

Recall Number: Z-0246-2023

Event ID: 91016

Reason for Recall:

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

Status: Completed

Product Quantity: 6 devices

Code Information:

Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.

Distribution Pattern:

US Nationwide distribution in the states of CA and NY.

Voluntary or Mandated:

Voluntary: Firm initiated