Device recall
Z-2164-2008: FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL…
FDA device recall · Class II · Ethicon Endo-Surgery Inc
Key facts
| Recall number (Z-number) | Z-2164-2008 |
|---|---|
| Recall event | 48604 |
| Product | FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. |
| Product code | FZT |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2012 |
| 510(k) numbers | K020779 |
| FEI number | 1527736 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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