Device recall
Z-0383-2018: PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis…
FDA device recall · Class II · TEI Biosciences
Key facts
| Recall number (Z-number) | Z-0383-2018 |
|---|---|
| Recall event | 78802 |
| Product | PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. |
| Product code | KGN |
| Recalling firm | TEI Biosciences |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2018 |
| 510(k) numbers | K153690 |
| FEI number | 3004170064 |
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