Device recall
Z-0989-2020: Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-0989-2020 |
|---|---|
| Recall event | 84639 |
| Product | Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture. |
| Product code | GAM |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2021 |
| 510(k) numbers | K022269 |
| FEI number | 2210968 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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