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

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Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries.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

A. PHYSIOMESH FLEXIBLE COMPOSITE MESH

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • PHY0715R
  • PHY1015V
  • PHY1515Q
  • PHY1520R
  • PHY1520V
  • PHY2025V
  • PHY2030R
  • PHY2535V
  • PHY3035R
  • PHY3050R
Companies
Manufacturer
JOHNSON & JOHNSON INTERNATIONAL, C/O EUROPEAN LOGISTICS CENTRE
LEONARDO DA VINCILAAN, 15, DIEGEM
BELGIUM