Device recall
Z-0421-2012: MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product…
FDA device recall · Class II · Orthohelix Surgical Designs Inc
Key facts
| Recall number (Z-number) | Z-0421-2012 |
|---|---|
| Recall event | 60454 |
| Product | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients… |
| Product code | HRS |
| Recalling firm | Orthohelix Surgical Designs Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2012 |
| 510(k) numbers | K102156 |
| 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