Events

Recall of McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inamed Corp.

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
    27294
  • Event Risk Class
    Class 3
  • Event Number
    Z-0006-04
  • Event Initiated Date
    2003-09-12
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29626
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled - Product Code FTR
  • Reason
    The 400cc, 460cc, 500cc and 560cc sizes of the mcghan style 40 silicone-filled breast implants were manufactured using one size smaller shells than required.
  • Action
    Recall was by letter to surgeons on 9/12/2003 which ask for return of unimplanted devices and an accounting of what is to be returned.

Device

McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Bar...
  • Model / Serial
    Serial numbers are too numerous to include.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier || Catalog Numbers: || 25-40401 || 25-40461 || 25-40501 || 25-40561
  • Manufacturer
    Inamed Corp

Manufacturer

Inamed Corp
  • Manufacturer Address
    Inamed Corp, 71 S Los Carneros, Goleta CA 93117
  • Source
    USFDA