| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00131-1 |
| Product Name/Description |
ISKD – Intramedullary Skeletal Kinetic Distractor (Limb Lengthener)
Model/Catalogue Numbers: F12-255-305, F12-300-350, F12-300-380, F12-345-395, F12-345-425, T12-300-380
All Lot/Serial Numbers
ARTG: 189940 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is a possibility that the ISKD limb lengthener may stop distracting during treatment may result in premature bone consolidation (limb not achieving the desired length), leading to revision surgery to remove and/or replace the device.
The recall action was not notified to the TGA before it was initiated by Akva Surgical |
| Recall Action |
Recall |
| Recall Action Instructions |
Discontinue the use of these devices. For patients currently having an ISKD limb lengthener implanted, surgeons are recommended to continue their prescribed post-operative activities and radiographic follow-up. |
| Contact Information |
03 9646 9292 - Akva Surgical |