Device recall
Z-1300-2022: DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used…
FDA device recall · Class II · CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
Key facts
| Recall number (Z-number) | Z-1300-2022 |
|---|---|
| Recall event | 90421 |
| Product | DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius. |
| Product code | LXT |
| Recalling firm | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2024 |
| 510(k) numbers | K050932 |
| FEI number | 3007923096 |
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