Events

Recall of ETCH GEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNCA MARKETING INC. ALSO OPERATING AS SYNCA.

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
    97406
  • Event Risk Class
    III
  • Event Initiated Date
    2011-06-14
  • 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
    Product continues to extrude out of the syringe even after pressure is no longer applied and the affected product actually contains a higher percentage of phosphoric acid than indicated on the label.

Device

ETCH GEL
  • Model / Serial
    Model Catalog: T06B (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: T06A (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: T06 (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: N01IB (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: N01H (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: T06B (Lot serial: all made since Apr 2007); Model Catalog: T06A (Lot serial: all made since Apr 2007); Model Catalog: T06 (Lot serial: all made since Apr 2007); Model Catalog: N01IB (Lot serial: all made since Apr 2007); Model Catalog: N01H (Lot serial: all made since Apr 2007); Model Catalog: T06B (Lot serial: N06K); Model Catalog: T06A (Lot serial: N06K); Model Catalog: T06 (Lot serial: N06K); Model Catalog: N01IB (Lot serial: N06K); Model Catalog: N01H (Lot serial: N06K); Model Catalog: T06B (Lot serial: N33); Model Catalog: T06A (Lot serial: N33); Model Catalog: T06 (Lot serial: N33); Model Catalog: N01IB (Lot serial: N33); Model Catalog: N01H (Lot serial: N33); Model Catalog: T06
  • Product Description
    37% Phosphoric Acid Etching Gel
  • Manufacturer
    SYNCA MARKETING INC. ALSO OPERATING AS SYNCA

Manufacturer

SYNCA MARKETING INC. ALSO OPERATING AS SYNCA