Device recall
Z-1389-2019: Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model)…
FDA device recall · Class II · Collagen Matrix, Inc.
Key facts
| Recall number (Z-number) | Z-1389-2019 |
|---|---|
| Recall event | 82638 |
| Product | Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge… |
| Product code | NPL |
| Recalling firm | Collagen Matrix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| 510(k) numbers | K003339, K011695 |
| FEI number | 3003300673 |
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