Device recall
Z-0480-2023: PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-0480-2023 |
|---|---|
| Recall event | 91192 |
| Product | PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery |
| Product code | NEW |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2210968 |
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