OneLIF Torque Limiting Adapter Recalled for Potential Locking Failure
Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical instrument component with a specific mechanical failure mode—the locking mechanism may not engage properly. This qualifies as a risk-of-harm product where injury has not yet been reported. No injuries or illnesses are documented in the source material.
Plain-English summary
Novapproach Spine LLC is recalling OneLIF Torque Limiting Adapter components (Catalog #015-010-0000), which are part of the NovApproach Spine OneLIF Interbody System instrument kit. Six devices have been identified in this recall.
The adapter is designed to lock securely inside the ratcheting handle. The identified defect is that the adapter may not stay locked once fully engaged, which could affect the proper function and control of the surgical instrument during spinal procedures.
The affected lot (Lot #104713, UDI G07001501000000) was distributed nationwide in California and New York. The affected kit IDs are 504, 505, 506, 501, 101, and 105. Users of these instruments should discontinue use and contact Novapproach Spine LLC for guidance on replacement or remedial action.
The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- 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.
- Manufacturer
- Novapproach Spine LLC
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Torque adapter - Lot #104713
- UDI G07001501000000
- Kit IDs - 504
- 505
- 506
- 501
- 101
- and 105.
Distribution
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