Device recall
Z-0458-2014: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-0458-2014 |
|---|---|
| Recall event | 66627 |
| Product | Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate. |
| Product code | NEW |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2016 |
| 510(k) numbers | K113004 |
| FEI number | 2210968 |
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