PHYSIOMESH FLEXIBLE COMPOSITE MESH (2016-05-25)

Starting date:

May 25, 2016

Posting date:

June 13, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58846

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  Reason
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  Affected products

Affected products

A. PHYSIOMESH FLEXIBLE COMPOSITE MESH

Reason

Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries. Recurrence / reoperation rates (respectively) after Laparoscopic Ventral Hernia Repair using ETHICON PHYSIOMESH Flexible Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Ethicon is unable at this time to characterize all factors contributing to higher rates and is therefore removing the product from the global market.

Affected products