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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 Life Healthcare Pty Ltd
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