Device recall
Z-0349-2007: DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained…
FDA device recall · Class III · OrthoHelix Surgical Designs Inc
Key facts
| Recall number (Z-number) | Z-0349-2007 |
|---|---|
| Recall event | 36843 |
| Product | DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36… |
| Product code | HRS |
| Recalling firm | OrthoHelix Surgical Designs Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 10, 2012 |
| 510(k) numbers | K053182 |
| FEI number | 3000718467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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