Device recall
Z-1538-2014: Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical…
FDA device recall · Class II · Biorep Technologies
Key facts
| Recall number (Z-number) | Z-1538-2014 |
|---|---|
| Recall event | 68093 |
| Product | Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery. |
| Product code | DWS |
| Recalling firm | Biorep Technologies |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2014 |
| FEI number | 3005593675 |
At a glance
- None Linked 510(k)s
- 1–9 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