Device recall
Z-0420-2011: Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended…
FDA device recall · Class II · Smith & Nephew, Inc. Endoscopy Division
Key facts
| Recall number (Z-number) | Z-0420-2011 |
|---|---|
| Recall event | 57041 |
| Product | Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy. |
| Product code | GAT |
| Recalling firm | Smith & Nephew, Inc. Endoscopy Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2012 |
| 510(k) numbers | K092508 |
| FEI number | 3003604053 |
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