Device recall
Z-1288-2015: LP Rotate Foot System prosthetic device for fitting lower extremity amputations…
FDA device recall · Class II · Ossur H / F
Key facts
| Recall number (Z-number) | Z-1288-2015 |
|---|---|
| Recall event | 70648 |
| Product | LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2)… |
| Product code | ISH |
| Recalling firm | Ossur H / F |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2015 |
| FEI number | 3003764610 |
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