Events

Recall of ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    142920
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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    Ethicon is recalling the product following an analysis of unpublished data from two large independent hernia registries.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.

Device

ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • Model / Serial
    Model Catalog: PHY3050R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY3035R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2535V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2030R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY0715R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1520R (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1515Q (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY1015V (Lot serial: >100 NUMBERS (ALL LOTS)); Model Catalog: PHY2025V (Lot serial: >100 NUMBERS (ALL LOTS))
  • Product Description
    PHYSIOMESH FLEXIBLE COMPOSITE MESH
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.