Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00743-1
Product Name/Description	GYNEMESH PS and TVT Devices Gynemesh PS Product Codes: GPSL and GPSXL3; TVT Devices Product Codes: 810041A, 810041B, 810081, TVTRL, TVTOML ARTG Number: 99193 (TVT) & 165075 (Gynemesh PS)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	2/09/2015
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a notification to inform hospitals and surgeons of changes to the Instructions for Use (IFU) for Ethicon GYNEMESH PS and TVT Devices. The changes include additional information on adverse reactions, warnings, precautions and patient selection.
Recall Action	Recall for Product Correction
Recall Action Instructions	Johnson & Johnson Medical (JJM) is issuing a notification to inform hospitals and healthcare professionals of changes to the Instructions for Use (IFU) for Ethicon GYNEMESH PS and TVT Devices. These changes have been made following the TGA’s clinical review of urogynaecological meshes and include additional information on include additional information on adverse events, warnings and contra-indications. This action has been closed-out on 22/08/2016.
Contact Information	1800 252 794 - Johnson & Johnson Medical