OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneL
FDA device recall Z-0246-2023 · posted 2022-11-17 · Terminated
Recall details
- Recalling firm
- Novapproach Spine LLC
- Reason for recall
- The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
- Action taken
- The recalling firm issued letters dated 10/10/2022 via email on 10/12/2022. The email briefly described the product to be recalled, the issue, and what the consignee needed to do. The letter, which was also mailed to the consignee via certified mail, return receipt, on 10/12/2022, describes the product, reason for recall, and provides the actions necessary to complete the product removal. The actions include immediately discontinuing use of the torque adapter, remove it from the consigned OneLIF INS-Instrument Kits(s), receive a replacement OneLIF Torque adapter Lot 106607 to add back to the kit, and receive a return label to return the torque adapter to the location provided. No response form was enclosed. The recalling firm will be coordinating with a third-party logistics provider to track the return of the product for quarantine and storage until all product has been returned.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OVD
- Quantity affected
- 6 devices
- Distribution
- US Nationwide distribution in the states of CA and NY.
- Date initiated
- 2022-10-12
- Date posted
- 2022-11-17
- Date terminated
- 2026-04-01
- Location
- Alachua, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OneLIF Intervertebral Body Replacement System (K211769) | Novapproach Spine | 2021-09-07 |