Recall Z-0246-2023— Novapproach Spine LLC
Class II · Terminated
Class II FDA medical device recall by Novapproach Spine LLC, initiated 2022-10-12, terminated 2026-04-01. It names one FDA 510(k) clearance: K211769. 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: The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged..
- Recalling firm
- Novapproach Spine LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-10-12
- Terminated
- 2026-04-01
- Firm location
- Alachua, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Data sourced from openFDA. This site is unofficial and independent of the FDA.