Device recall
Z-2138-2008: GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N…
FDA device recall · Class II · Synovis Micro Companies Alliance Inc
Key facts
| Recall number (Z-number) | Z-2138-2008 |
|---|---|
| Recall event | 48974 |
| Product | GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures. |
| Product code | MVR |
| Recalling firm | Synovis Micro Companies Alliance Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2010 |
| 510(k) numbers | K040163 |
| FEI number | 3000302153 |
At a glance
- 1–9 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