Events

Recall of TI-MAX X CONTRA/HP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PATTERSON DENTAL CANADA 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
    84705
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-28
  • 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
    Nakanishi updated the operation manual to include clarifications and details regarding the proper maintenance of the handpieces and how proper maintenance can reduce the risk of injury to patients.

Device

TI-MAX X CONTRA/HP
  • Model / Serial
    Model Catalog: X85L (Lot serial: All Serial #); Model Catalog: Z95L (Lot serial: All Serial #); Model Catalog: M95L (Lot serial: All Serial #); Model Catalog: X95L (Lot serial: All Serial #); Model Catalog: X95EX (Lot serial: All Serial #); Model Catalog: X85 (Lot serial: All Serial #); Model Catalog: X95 (Lot serial: All Serial #); Model Catalog: SGA-E2S (Lot serial: All Serial #); Model Catalog: TI95EX (Lot serial: All Serial #); Model Catalog: Z45L (Lot serial: All Serial #); Model Catalog: SGES (Lot serial: All Serial #); Model Catalog: SGSE2S (Lot serial: All Serial #); Model Catalog: XS93 (Lot serial: All Serial #); Model Catalog: XSG93L (Lot serial: All Serial #); Model Catalog: Z85L (Lot serial: All Serial #); Model Catalog: M95 (Lot serial: All Serial #)
  • Product Description
    TI-MAX X Contra/HP;TI-MAX Z Contra/HP;S-MAX M Contra/HP;Micro Surgery Handpiece SGA;TI95EX Contra;TI-MAX Z45 Contra;Micro Surgery Handpiece SGS;TI-MAX X-SG Contra
  • Manufacturer
    PATTERSON DENTAL CANADA INC.

Manufacturer

PATTERSON DENTAL CANADA INC.