Device recall
Z-0791-2013: Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta…
FDA device recall · Class II · Medacta Usa Inc
Key facts
| Recall number (Z-number) | Z-0791-2013 |
|---|---|
| Recall event | 64160 |
| Product | Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery. |
| Product code | MEH |
| Recalling firm | Medacta Usa Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2013 |
| 510(k) numbers | K072857, K082792, K083558, K093944, K103189 |
| FEI number | 3006639916 |
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