Device recall
Z-2486-2012: Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-2486-2012 |
|---|---|
| Recall event | 63073 |
| Product | Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The… |
| Product code | HXX |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2013 |
| FEI number | 1825034 |
At a glance
- None 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