Device recall
Z-0403-2021: DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344…
FDA device recall · Class III · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-0403-2021 |
|---|---|
| Recall event | 86545 |
| Product | DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the… |
| Product code | MQP |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 30, 2022 |
| 510(k) numbers | K003275, K983766 |
| FEI number | 3008812560 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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