Device recall
Z-0136-2008: DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw…
FDA device recall · Class II · OrthoHelix Surgical Designs Inc
Key facts
| Recall number (Z-number) | Z-0136-2008 |
|---|---|
| Recall event | 44883 |
| Product | DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate; Distal Screw Part… |
| Product code | HRS |
| Recalling firm | OrthoHelix Surgical Designs Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2011 |
| 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