Device recall
Z-3104-2017: JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended…
FDA device recall · Class II · Stanmore Implants Worldwide Ltd.
Key facts
| Recall number (Z-number) | Z-3104-2017 |
|---|---|
| Recall event | 77753 |
| Product | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur. |
| Product code | KRO |
| Recalling firm | Stanmore Implants Worldwide Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2021 |
| 510(k) numbers | K092138, K133152, K140898 |
| FEI number | 3004105610 |
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