Events

Recall of STERLING BURRS AND ROUTER

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

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
    55207
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-21
  • 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
    This recall has been initiated due to an assembly error caused by the inadvertent mixing of two sizes of bearings which occurred on the manufacturing line. conmed received 10 complaints of metal shavings coming from the burs during use due to contact between the bur and the hood of the prebent bur assembly. this could potentially render the device inoperable and could potentially cause a minor injury to the patient if the metal debris drops into the patient operative site. in no instance has it been reported to conmed corporation that this issue has resulted in illness or injury. all lots codes of catalog no. hps-hb11 hps-hb12 and hps-hb13 (hip preservation system signature series prebent burs) manufactured from june 18 2014 through to october 2 2015 are being removed from the market by this recall action.

Device

STERLING BURRS AND ROUTER
  • Model / Serial
    Model Catalog: HPS-HB11 (Lot serial: ALL LOTS); Model Catalog: HPS-HB13 (Lot serial: ALL LOTS)
  • Product Description
    PREBENT BURS
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC