Device recall
Z-2269-2014: Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a…
FDA device recall · Class II · Gyrus Medical, Inc
Key facts
| Recall number (Z-number) | Z-2269-2014 |
|---|---|
| Recall event | 68768 |
| Product | Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical… |
| Product code | KNH |
| Recalling firm | Gyrus Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2015 |
| PMA numbers | P870076 |
| FEI number | 3011050570 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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