Device recall
Z-1265-2011: 02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of…
FDA device recall · Class II · Synthes USA (HQ), Inc.
Key facts
| Recall number (Z-number) | Z-1265-2011 |
|---|---|
| Recall event | 57318 |
| Product | 02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. |
| Product code | KTW |
| Recalling firm | Synthes USA (HQ), Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2015 |
| 510(k) numbers | K080109 |
| FEI number | 3005180112 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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