Device recall
Z-0367-2016: PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant…
FDA device recall · Class II · Merz North America, Inc.
Key facts
| Recall number (Z-number) | Z-0367-2016 |
|---|---|
| Recall event | 72591 |
| Product | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. |
| Product code | MIX |
| Recalling firm | Merz North America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2017 |
| 510(k) numbers | K060815 |
| FEI number | 1012187 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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