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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00856-1
Product Name/Description	Torque Limiting Adapter for use in orthopaedic and trauma surgical procedures (Re-useable surgical instrument) Part Number: 00-2360-080-00 All lot numbers affected ARTG Number: 260719
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/06/2016
Responsible Entity	Zimmer Pty Ltd
Reason/Issue	The manufacturer, Greatbatch Medical identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on Torque Limiting Adapter when subjected to steam sterilisation cycles identified in the Instructions For Use (IFU) provided with the device. Torque Limiting Adapter is supplied non-sterile and requires cleaning and steam sterilisation prior to use and subsequent re-use.
Recall Action	Recall
Recall Action Instructions	Zimmer Biomet is advising users to immediately locate and remove the identified device. Zimmer Biomet will remove the affected product from the facility.
Contact Information	02 9483 5426 - Zimmer Biomet