Device recall
Z-0550-2015: Gardner-Wells traction tongs are skull tongs for traction used to immobilize a…
FDA device recall · Class II · Instrumed International, Inc.
Key facts
| Recall number (Z-number) | Z-0550-2015 |
|---|---|
| Recall event | 69471 |
| Product | Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand… |
| Product code | HAX |
| Recalling firm | Instrumed International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2017 |
| FEI number | 1421101 |
At a glance
- None Linked 510(k)s
- 10–99 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