Device recall
Z-2457-2012: The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base…
FDA device recall · Class II · Integra Limited
Key facts
| Recall number (Z-number) | Z-2457-2012 |
|---|---|
| Recall event | 62711 |
| Product | The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to… |
| Product code | FWZ |
| Recalling firm | Integra Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 20, 2013 |
| FEI number | 3001700044 |
At a glance
- None 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