Events

Recall of Device Recall Natrelle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allergan 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
    71428
  • Event Risk Class
    Class 2
  • Event Number
    Z-1988-2015
  • Event Initiated Date
    2015-06-08
  • Event Date Posted
    2015-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137741
  • 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
    Sizer, mammary, breast implant volume - Product Code MRD
  • Reason
    Allergan is recalling the natrelle 410cc re-sterilizable breast implant sizer because the expired product was shipped to the user level.
  • Action
    A recall letter dated 6/8/15 was sent to all customers who received the NATRELLE 410 cc Re-Sterilizable Breast Implant Sizer. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST. On June 12, 2015, Actavis sent follow up letters to customers to include one additional serial number.

Device

Device Recall Natrelle
  • Model / Serial
    Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    CA, IN, MO, NJ, VA
  • Product Description
    Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. || The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
  • Manufacturer
    Allergan Inc

Manufacturer

Allergan Inc