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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01337-1
Product Name/Description	Thoracic Pedicle Feeler Item Number: 6002-350-000 (contained within tray 6001035000-T) Serial Number: 10910 ARTG Number: 175054
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/10/2017
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has determined that a laser marking machine used to create the distance markings on the tip of the Thoracic Pedicle Feeler has settings higher than those intended. This change leads to an increased energy being directed onto the tip of the Thoracic Pedicle Feeler, causing material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break during use. If this occurs within the patient, migration of the broken tip could result in soft tissue or peripheral nerve injury requiring surgical intervention.
Recall Action	Recall
Recall Action Instructions	Stryker is advising users to quarantine any affected product and contact their local Stryker representative to coordinate the return and replacement of affected product. This action has been closed out on the 12/11/2018.
Contact Information	02 9467 1175 - Stryker