Device recall
Z-0246-2023: OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog…
FDA device recall · Class II · Novapproach Spine LLC
Key facts
| Recall number (Z-number) | Z-0246-2023 |
|---|---|
| Recall event | 91016 |
| 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. |
| Product code | OVD |
| Recalling firm | Novapproach Spine LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2026 |
| 510(k) numbers | K211769 |
| FEI number | 3020307303 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database