Device recall
Z-0040-2020: CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large)…
FDA device recall · Class II · AZIYO BIOLOGICS
Key facts
| Recall number (Z-number) | Z-0040-2020 |
|---|---|
| Recall event | 83652 |
| Product | CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope… |
| Product code | FTM |
| Recalling firm | AZIYO BIOLOGICS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 17, 2020 |
| 510(k) numbers | K140306, K173242, K182255 |
| 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