Device recall
Z-1379-2013: Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020…
FDA device recall · Class II · Orthopedic Alliance LLC
Key facts
| Recall number (Z-number) | Z-1379-2013 |
|---|---|
| Recall event | 64588 |
| Product | Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial… |
| 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