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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00214-1
Product Name/Description	METS Modular Tumour System Item Numbers: mkfh/SmSt, mkrhm/SmLg, mkrhm/StdSt, msfshft/135, msfshft/150, msiss/15x27C, msiss/O15x30x38C, msiss/O15x36x44C, msiss/O30x30x38C Multiple Batch Numbers ARTG Numbers: 278135, 278137, 246516, 276028, 278138
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/02/2017
Responsible Entity	Corin Australia Pty Ltd
Reason/Issue	There have been reports that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the METS Modular Tumour System's stem feature. In some instances, the implant assemblies have punctured through both inner and outer pouches, compromising the sterile barrier and causing internal damage to the device carton.
Recall Action	Hazard Alert
Recall Action Instructions	Stryker is advising surgeons to monitor patients through regular consultations to determine the need for any treatment. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG
Contact Information	02 9467 1175 - Stryker Recall Specialist