Print version of this report
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