Events

Recall of Device Recall McGhan Style 163360cc SalineFilled BIOCELL textured Breast Implants

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
    34256
  • Event Risk Class
    Class 3
  • Event Number
    Z-0337-06
  • Event Initiated Date
    2005-12-14
  • Event Date Posted
    2005-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43348
  • 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, Inflatable, Internal, Saline - Product Code FWM
  • Reason
    Two lots of products were mislabeled; a lot of twenty style 468 breast implants and a lot of twenty style 163 breast implants. in error, the labels for these two lots were switched during packaging. as a result, a total of 40 devices were mislabeled.
  • Action
    On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.

Device

Device Recall McGhan Style 163360cc SalineFilled BIOCELL textured Breast Implants
  • Model / Serial
    Lot#1121514, Serial# 11567927 & 11567935
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
  • Manufacturer
    Inamed Corp

Manufacturer

Inamed Corp
  • Manufacturer Address
    Inamed Corp, 71 S Los Carneros Rd, Goleta CA 93117-5506
  • Source
    USFDA