Events

Recall of HI-LINE XS DISP.DIAMOND BURR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AESCULAP AG.

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
    140208
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-11
  • 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
    It was observed that during operation particles can break away from the diamond burr and fall into the situs. if the particles are not detected after breaking away and are not removed from the wound the particles can remain to a certain extent in the patient's body.

Device

HI-LINE XS DISP.DIAMOND BURR
  • Model / Serial
    Model Catalog: GE613SU-GE627SU (Lot serial: 51468627); Model Catalog: GE613SU-GE627SU (Lot serial: 51676480); Model Catalog: GE410SU-GE431SU (Lot serial: 51676479); Model Catalog: GE511SU-GE531SU (Lot serial: 51593790); Model Catalog: GE410SU-GE431SU (Lot serial: 51593790); Model Catalog: GE511SU-GE531SU (Lot serial: 51676479)
  • Product Description
    Hi-Line XS DISP.Diamond Burr;Hi-Line Burr Diamond
  • Manufacturer
    AESCULAP AG

Manufacturer

AESCULAP AG