Device recall
Z-1378-2013: Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR…
FDA device recall · Class II · Orthopedic Alliance LLC
Key facts
| Recall number (Z-number) | Z-1378-2013 |
|---|---|
| Recall event | 64588 |
| Product | Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral component, CR, cemented, #6… |
| Product code | JWH |
| Recalling firm | Orthopedic Alliance LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2014 |
| 510(k) numbers | K120507 |
| 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