Device recall
Z-2423-2018: Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage…
FDA device recall · Class II · Anika Therapeutics, Inc.
Key facts
| Recall number (Z-number) | Z-2423-2018 |
|---|---|
| Recall event | 80291 |
| Product | Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid… |
| Product code | FRO |
| Recalling firm | Anika Therapeutics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2019 |
| 510(k) numbers | K073251 |
| FEI number | 3007093114 |
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