Device recall
Z-1915-2015: DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1915-2015 |
|---|---|
| Recall event | 71361 |
| Product | DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and… |
| Product code | HSB |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 18, 2015 |
| 510(k) numbers | K040336 |
| FEI number | 3005180112 |
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