Device recall
Z-0414-2019: BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
FDA device recall · Class III · Collagen Matrix, Inc.
Key facts
| Recall number (Z-number) | Z-0414-2019 |
|---|---|
| Recall event | 81282 |
| Product | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. |
| Product code | LYC |
| Recalling firm | Collagen Matrix, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 23, 2020 |
| 510(k) numbers | K062846 |
| 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