Device recall
Z-1173-2016: ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in…
FDA device recall · Class III · Collagen Matrix Inc
Key facts
| Recall number (Z-number) | Z-1173-2016 |
|---|---|
| Recall event | 73208 |
| Product | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar… |
| Product code | NPM |
| Recalling firm | Collagen Matrix Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 10, 2018 |
| 510(k) numbers | K140714 |
| 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