Device recall
Z-0747-2019: PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-0747-2019 |
|---|---|
| Recall event | 81820 |
| Product | PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. |
| Product code | GAP |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2020 |
| 510(k) numbers | K946173 |
| 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