Device recall
Z-0448-05: ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which…
FDA device recall · Class II · Warsaw Orthopedic, Inc.
Key facts
| Recall number (Z-number) | Z-0448-05 |
|---|---|
| Recall event | 30854 |
| Product | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127. |
| Product code | HWC |
| Recalling firm | Warsaw Orthopedic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2005 |
| FEI number | 1824199 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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