Device recall
Z-1174-2009: Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm)…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1174-2009 |
|---|---|
| Recall event | 51402 |
| Product | Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810. Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA. |
| Product code | FRO |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2009 |
| 510(k) numbers | K021792 |
| FEI number | 3003418325 |
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