Device recall
Z-0362-2014: Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component…
FDA device recall · Class II · Ossur North America Inc
Key facts
| Recall number (Z-number) | Z-0362-2014 |
|---|---|
| Recall event | 66609 |
| Product | Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in… |
| Product code | ISH |
| Recalling firm | Ossur North America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2014 |
| FEI number | 1000519909 |
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