Device recall
Z-0039-2020: BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope…
FDA device recall · Class II · AZIYO BIOLOGICS
Key facts
| Recall number (Z-number) | Z-0039-2020 |
|---|---|
| Recall event | 83652 |
| Product | BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack)… |
| Product code | FTM |
| Recalling firm | AZIYO BIOLOGICS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 17, 2020 |
| 510(k) numbers | K140306 |
| FEI number | 3005619880 |
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