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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