Events

Recall of Style 363 Saline-Filled 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
    32063
  • Event Risk Class
    Class 2
  • Event Number
    Z-0851-05
  • Event Initiated Date
    2005-05-05
  • Event Date Posted
    2005-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39064
  • 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
    Wrong size implant was mislabeled.
  • Action
    Firm sent letter by overnite mail on May 5, 2005. Follow-up phone calls were made to confirm reciept. Doctors are to review surgery records and evaluate ammount of saline used to determine the risk for folding occuring and if found a visit by the patient is recommended to further evaluate for folding.

Device

Style 363 Saline-Filled BIOCELL textured Breast Implants
  • Model / Serial
    UF6328, UF6330, UF6331, UM5056, UM5057, UM5059
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    WI, TN, TX, NY, AR
  • Product Description
    Style 363 Saline-Filled BIOCELL textured Breast Implants
  • Manufacturer
    Inamed Corp

Manufacturer

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