Events

Recall of VICTORY SERIES BUCCAL TUBES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by 3M UNITEK CORPORATION DBA 3M UNITEK ORTHODONTIC PRODUCTS.

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
    73857
  • Event Risk Class
    III
  • Event Initiated Date
    2015-09-22
  • 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 inner label of the buccal tube itself shows a notation (palmer notation) indicating that the contents are a lower right buccal tube when in fact the contents are a lower left buccal tube. the part number is correct on the inner label. the part number and palmer notation on the outer label (of a 5-pack box) are correct.

Device

VICTORY SERIES BUCCAL TUBES
  • Model / Serial
    Model Catalog: 3067-9773 (Lot serial: GR3FB); Model Catalog: 3067-9013 (Lot serial: GR3FB); Model Catalog: 3066-5033 (Lot serial: GR1MA); Model Catalog: 3067-6363 (Lot serial: GR1MA); Model Catalog: 3067-6363 (Lot serial: GR3FB); Model Catalog: 3066-5033 (Lot serial: GR3FB); Model Catalog: 3067-9773 (Lot serial: GR4SP); Model Catalog: 3067-9013 (Lot serial: GR4SP); Model Catalog: 3067-6363 (Lot serial: GR4SP); Model Catalog: 3066-5033 (Lot serial: GR4SP); Model Catalog: 3067-9773 (Lot serial: GQ9AE); Model Catalog: 3067-9013 (Lot serial: GQ9AE); Model Catalog: 3067-6363 (Lot serial: GQ9AE); Model Catalog: 3066-5033 (Lot serial: GQ9AE); Model Catalog: 3067-9773 (Lot serial: GR2LA); Model Catalog: 3067-9013 (Lot serial: GR2LA); Model Catalog: 3067-6363 (Lot serial: GR2LA); Model Catalog: 3066-5033 (Lot serial: GR2LA); Model Catalog: 3067-9773 (Lot serial: GR1MA); Model Catalog: 3067-9013 (Lot serial: GR1MA)
  • Product Description
    APC II Victory Series Buccal Tubes
  • Manufacturer
    3M UNITEK CORPORATION DBA 3M UNITEK ORTHODONTIC PRODUCTS

Manufacturer

3M UNITEK CORPORATION DBA 3M UNITEK ORTHODONTIC PRODUCTS
  • Manufacturer Address
    MONROVIA
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    HC