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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00699-1
Product Name/Description	Ethicon Physiomesh Flexible Composite Mesh All Product Codes and Lot Numbers affected ARTG Number: 182785
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/05/2016
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a medical device recall, in line with an Ethicon initiated worldwide medical device removal, of Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). The product is being removed following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using Ethicon Physiomesh Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical advises customers to inspect stocks and immediately quarantine any affected units prior to their return. The management of patients who have been treated using ETHICON PHYSIOMESH Composite Mesh will remain at the discretion of the treating health care practitioner. A Hazard alert letter will be sent to Surgeons.
Contact Information	1800 252 194 (Option 4) - JJM Product Safety 02 9815 3658 - JJM Return of Product