| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01443-1 |
| Product Name/Description |
Kasios TCP and Kages
Kasios TCP, Kage, RSF, Wedge Kage, TLIF Kage RSF
Multiple Item and Lot Numbers
ARTG Numbers: 192697, 186610, 141918, 178660 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified during the validation verification of the sterilisation procedures. There is a risk in connection to sterilisation conformity for specific batches. This could lead to an increased risk of infection in the days following surgery. No adverse event has been reported worldwide in relation to this issue. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Life Healthcare is advising surgeons to review their patients who have been implanted with the affected products for any post-operative infection.
This action has been closed-out on 22/03/2018. |
| Contact Information |
02 8114 1531 - Life Healthcare |