Events

Recall of ROUND HIGH PROFILE RESTERILIZABLE GEL BREAST IMPLANT SIZER

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
    25664
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-14
  • 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
    A previously discontinued health canada licensed mentor non-sterile gel breast implant sizer was incorrectly distributed to several customers in canada when the customer order was for the sterile version of the same product. the sterile version of the product is licensed with health canada.

Device

ROUND HIGH PROFILE RESTERILIZABLE GEL BREAST IMPLANT SIZER
  • Model / Serial
    Model Catalog: RSZ-4754 (Lot serial: 6657792); Model Catalog: RSZ-7504 (Lot serial: 6571808); Model Catalog: RSZ-4754 (Lot serial: 6571808); Model Catalog: RSZ-7504 (Lot serial: 6492914); Model Catalog: RSZ-4754 (Lot serial: 6492914); Model Catalog: RSZ-7504 (Lot serial: 6406134); Model Catalog: RSZ-4754 (Lot serial: 6406134); Model Catalog: RSZ-7504 (Lot serial: 6434505); Model Catalog: RSZ-4754 (Lot serial: 6434505); Model Catalog: RSZ-7504 (Lot serial: 6623189); Model Catalog: RSZ-4754 (Lot serial: 6623189); Model Catalog: RSZ-7504 (Lot serial: 6652667); Model Catalog: RSZ-4754 (Lot serial: 6652667); Model Catalog: RSZ-7504 (Lot serial: 6656806); Model Catalog: RSZ-4754 (Lot serial: 6656806); Model Catalog: RSZ-7504 (Lot serial: 6659170); Model Catalog: RSZ-4754 (Lot serial: 6659170); Model Catalog: RSZ-7504 (Lot serial: 6665665); Model Catalog: RSZ-4754 (Lot serial: 6665665); Model Catalog: RSZ-7504 (Lot serial: 6657792); Model Catalog: RSZ-5251 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: RSZ-4
  • Product Description
    HIGH PROFILE RESTERILIZABLE SIZER
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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