Events

Recall of RE-STERILIZABLE SIZER INSPIRA MP

According to Health Canada (via FOI), this recall involved a device in Canada 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
    36601
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-09
  • 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
    The fill volume information (black stamp) printed on the natrelle re-sterilizable breast implant sizers incorrectly states 345cc and does not coincide with the correct fill volume information printed on the device labels and the embossed product patch (375cc).

Device

RE-STERILIZABLE SIZER INSPIRA MP
  • Model / Serial
    Model Catalog: N-SZRM375 (Lot serial: 20741123); Model Catalog: N-SZRM375 (Lot serial: 20741121); Model Catalog: N-SZRM375 (Lot serial: 20741120); Model Catalog: N-SZRM375 (Lot serial: 20741122)
  • Product Description
    RE-STERILIZABLE SIZER INSPIRA MP
  • Manufacturer
    ALLERGAN INC.

Manufacturer

ALLERGAN INC.