Device recall
Z-1611-2009: Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS…
FDA device recall · Class II · Stryker Spine
Key facts
| Recall number (Z-number) | Z-1611-2009 |
|---|---|
| Recall event | 52090 |
| Product | Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp; 325 Corporate Drive, Mahwah, NJ 07430. The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative… |
| Product code | MNH |
| Recalling firm | Stryker Spine |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2013 |
| 510(k) numbers | K061813 |
| FEI number | 3004024955 |
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