Recall Z-0246-2023 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Novapproach Spine LLC
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.
| Date | Nov 17, 2022 (initiated Oct 12, 2022) |
| Status | Terminated |
| Reason | The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. |
| Root cause | Nonconforming Material/Component |
| Action | 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 th |
| Quantity | 6 devices |
| Distribution | US Nationwide distribution in the states of CA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211769 | OneLIF Intervertebral Body Replacement System Novapproach Spine, Sep 7, 2021 |