Events

Recall of SELF-DRILLING SCHANZ SCREW

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNTHES (U.S.A.).

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
    18667
  • Event Risk Class
    III
  • 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 raw material did not meet the specifications.

Device

SELF-DRILLING SCHANZ SCREW
  • Model / Serial
    Model Catalog: (Lot serial: ITEM 294.796); Model Catalog: (Lot serial: LOT 4335468 4336190)
  • Product Description
    SELF DRILLIN SCHANZ SCEW
  • Manufacturer
    SYNTHES (U.S.A.)

Manufacturer

SYNTHES (U.S.A.)
  • Manufacturer Address
    PAOLI
  • Source
    HC