Device recall
Z-1754-2013: AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408…
FDA device recall · Class I · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-1754-2013 |
|---|---|
| Recall event | 65553 |
| Product | AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. |
| Product code | MAL |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| 510(k) numbers | K093231, K103080 |
| FEI number | 1220948 |
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