Device recall
Z-2818-2011: Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-2818-2011 |
|---|---|
| Recall event | 59104 |
| Product | Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery |
| Product code | GAP |
| Recalling firm | Covidien LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2014 |
| 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