Device recall
Z-1176-2023: Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK…
FDA device recall · Class II · Covidien, LP
Key facts
| Recall number (Z-number) | Z-1176-2023 |
|---|---|
| Recall event | 91324 |
| Product | Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM… |
| Product code | GAP |
| Recalling firm | Covidien, LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K981128 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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