Device recall
Z-0398-2021: TroClose 1200 - Product Usage: intended for use in a variety of gynecologic…
FDA device recall · Class II · Gordian Surgical
Key facts
| Recall number (Z-number) | Z-0398-2021 |
|---|---|
| Recall event | 86483 |
| Product | TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / laparoscopic surgery… |
| Product code | GAM |
| Recalling firm | Gordian Surgical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2021 |
| 510(k) numbers | K160564, K171494 |
| FEI number | 3011803381 |
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