Device recall
Z-2532-2018: PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18")…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-2532-2018 |
|---|---|
| Recall event | 80401 |
| Product | PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983) |
| Product code | NEW |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2020 |
| 510(k) numbers | K061037 |
| 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