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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The product is being removed following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB).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