Device recall
Z-0845-2024: Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-0845-2024 |
|---|---|
| Recall event | 93768 |
| Product | Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36… |
| Product code | GAP |
| Recalling firm | Covidien LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K981128 |
| FEI number | 1282497 |
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