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.
Reported: November 23, 2022 Initiated: October 12, 2022 #Z-0246-2023
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.
Details
- Recalling Firm
- Novapproach Spine LLC
- Units Affected
- 6 devices
- Distribution
- US Nationwide distribution in the states of CA and NY.
- Location
- Alachua, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Novapproach Spine LLC. Units affected: 6 devices.
Why was this product recalled? ▼
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0246-2023.
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