Device recall
Z-1243-2019: EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm)…
FDA device recall · Class II · Molnlycke Health Care, Inc
Key facts
| Recall number (Z-number) | Z-1243-2019 |
|---|---|
| Recall event | 82522 |
| Product | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated… |
| Product code | KGN |
| Recalling firm | Molnlycke Health Care, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2021 |
| 510(k) numbers | K935189 |
| FEI number | 1629080 |
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