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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00574-1
Product Name/Description SERFAS 90° Energy Probe (90R Probe)
(Electrosurgical system electrode)

Item Number: 279-350-101

Affected Lots: 13128AE2 to 14337AE2

ARTG Number: 146512
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/06/2015
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker has been made aware of a spike in the occurrence of tip breaks identified for the 90R Probe. The investigation triggered by same confirmed the shape and location of the tip break in each case to be the same. In each event a small piece from the distal end of the alumina ceramic broke off. The geometry of this type of crack differs from those normally observed by SERFAS probes.
Recall Action Recall
Recall Action Instructions Customers are asked to check any SERFAS 90° Energy Probe items in their possession and quarantine any affected units immediately . A Stryker Representative will coordinate an inspection of your affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued. This action has been closed-out on 08/08/2016.
Contact Information 1800 803 601 - RAQA Coordinator