Device recall
Z-0712-2018: ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in…
FDA device recall · Class II · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-0712-2018 |
|---|---|
| Recall event | 79293 |
| Product | ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. |
| Product code | FTL |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 30, 2018 |
| 510(k) numbers | K151437 |
| FEI number | 3011175548 |
At a glance
- 1–9 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