Device recall
Z-1386-2013: Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long…
FDA device recall · Class II · Orthopedic Alliance LLC
Key facts
| Recall number (Z-number) | Z-1386-2013 |
|---|---|
| Recall event | 64588 |
| Product | Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr Ball Head, 28 XX-Long CoCr Ball… |
| Product code | LZO |
| Recalling firm | Orthopedic Alliance LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2014 |
| 510(k) numbers | K112463 |
| 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