Device recall
Z-3081-2011: Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901…
FDA device recall · Class II · Orthohelix Surgical Designs Inc
Key facts
| Recall number (Z-number) | Z-3081-2011 |
|---|---|
| Recall event | 59462 |
| Product | Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to… |
| Product code | HRS |
| Recalling firm | Orthohelix Surgical Designs Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2012 |
| 510(k) numbers | K101962 |
| 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