Device recall
Z-1380-2013: UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large…
FDA device recall · Class II · Orthopedic Alliance LLC
Key facts
| Recall number (Z-number) | Z-1380-2013 |
|---|---|
| Recall event | 64588 |
| Product | UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large… |
| Product code | JWH |
| Recalling firm | Orthopedic Alliance LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2014 |
| 510(k) numbers | K103733 |
| FEI number | 3004022256 |
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