OneLIF Torque Limiting Adapter recall
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…
Why was OneLIF Torque Limiting Adapter recalled?
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.
- 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…
- Recalling firm
- Novapproach Spine LLC
- Quantity
- 6 devices
- Distribution
- US Nationwide distribution in the states of CA and NY.
- Recall date
- November 23, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)