Device recall
Z-1616-2016: Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to…
FDA device recall · Class II · Atlas Spine, Inc.
Key facts
| Recall number (Z-number) | Z-1616-2016 |
|---|---|
| Recall event | 73657 |
| Product | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position |
| Product code | MQP |
| Recalling firm | Atlas Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2019 |
| 510(k) numbers | K063205, K091406 |
| FEI number | 3003855635 |
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