Device recall
Z-1352-2015: Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1352-2015 |
|---|---|
| Recall event | 70579 |
| Product | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth… |
| Product code | HSB |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2015 |
| 510(k) numbers | K131548 |
| 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