Device recall
Z-1082-2016: Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1082-2016 |
|---|---|
| Recall event | 73140 |
| Product | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK… |
| Product code | LXT |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 5, 2017 |
| 510(k) numbers | K112345 |
| FEI number | 1825034 |
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