Device recall
Z-0368-2016: PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA)…
FDA device recall · Class II · Merz North America, Inc.
Key facts
| Recall number (Z-number) | Z-0368-2016 |
|---|---|
| Recall event | 72591 |
| Product | PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency. |
| Product code | KHJ |
| Recalling firm | Merz North America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2017 |
| 510(k) numbers | K013243 |
| 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