Events

Recall of CK-3 LARGE FULL RADIUS SIDES SCALPEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SINCLAIR DENTAL CO. LTD..

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
    42076
  • Event Risk Class
    III
  • Event Initiated Date
    2011-07-04
  • 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
    One lot of scalpel packages labeled as ck-3 large full radius scalpel part # 975-0011 actually contained ck-6 small full radius scalpel. the package listed the correct part number but included the incorrect part.

Device

CK-3 LARGE FULL RADIUS SIDES SCALPEL
  • Model / Serial
    Model Catalog: 975-0011 (Lot serial: 100813)
  • Product Description
    CK-3 Large Full Radius Scalpel
  • Manufacturer
    SINCLAIR DENTAL CO. LTD.

Manufacturer

SINCLAIR DENTAL CO. LTD.