Novapproach Spine LLC Recall 91016
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.
Novapproach Spine LLC Recall 91016 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0246-2023 |
| Event ID | 91016 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA and NY. |
| Quantity | 6 devices |
| Recall Reason | The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. |
| Device Classification | 20221123 |
| Device Code Info | Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105. |
| Center Classification Date | 20221117 |
| Recall Initiation Date | 20221012 |
| Recalling Firm | Novapproach Spine LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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