Events

Recall of LUTE-IT ESTHETIC LUTING SYSTEM REFILLS

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
    56268
  • Event Risk Class
    III
  • Event Initiated Date
    2010-07-29
  • 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 is gelling inside the bottle. this recall is an extention of the bond-1 primer/adhesive recall that was initiated in august 2009 (incident 50640).

Device

LUTE-IT ESTHETIC LUTING SYSTEM REFILLS
  • Model / Serial
    Model Catalog: N04B (Lot serial: Package Lt#: 183127); Model Catalog: N04 (Lot serial: Package Lt#: 183127); Model Catalog: N04B (Lot serial: Bottle Lt#: 185597); Model Catalog: N04 (Lot serial: Bottle Lt#: 185597); Model Catalog: N04B (Lot serial: Bottle Lt#: 191010); Model Catalog: N04 (Lot serial: Bottle Lt#: 191010); Model Catalog: N04B (Lot serial: Package Lt#: 202891); Model Catalog: N01I (Lot serial: Package Lt#: 200960); Model Catalog: N01I (Lot serial: Package Lt#: 197439); Model Catalog: N01I (Lot serial: Package Lt#: 192720); Model Catalog: N01I (Lot serial: Package Lt#: 186193); Model Catalog: N01I (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N01I (Lot serial: Package Lt#: 194491); Model Catalog: N01I (Lot serial: Package Lt#: 186658); Model Catalog: N01I (Lot serial: Bottle Lt#: 192338); Model Catalog: N01I (Lot serial: Bottle Lt#: 1855297); Model Catalog: N01I (Lot serial: Bottle Lt#: 202233); Model Catalog: N01I (Lot serial: Bottle Lt#: 200864); Model Catalog: N01I (Lot serial: Bottle
  • Product Description
    LUTE-IT ESTHETIC LUTING SYSTEM REFILLS
  • Manufacturer
    SYNCA MARKETING INC. ALSO OPERATING AS SYNCA

Manufacturer

SYNCA MARKETING INC. ALSO OPERATING AS SYNCA