Device recall
Z-1032-2019: Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948…
FDA device recall · Class II · ACell, Inc
Key facts
| Recall number (Z-number) | Z-1032-2019 |
|---|---|
| Recall event | 82228 |
| Product | Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of… |
| Product code | FTM |
| Recalling firm | ACell, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2020 |
| 510(k) numbers | K170763 |
| FEI number | 3005920706 |
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