Events

Recall of UNI-PUNCH DISPOSABLE BIOPSY PUNCH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PREMIER DENTAL PRODUCTS COMPANY ALSO DBA PREMIER MEDICAL.

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
    22707
  • Event Risk Class
    III
  • Event Initiated Date
    2012-11-30
  • 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
    Premier dental products company does not hold a licence for the class ii medical device uni-punch disposable biopsy punch for which premier products company is identified as the manufacturer.

Device

UNI-PUNCH DISPOSABLE BIOPSY PUNCH
  • Model / Serial
    Model Catalog: 9033502 9033503 9033504 (Lot serial: all); Model Catalog: 9033505 9033506 9033508 (Lot serial: all); Model Catalog: 9033509 9033510 9033511 (Lot serial: all); Model Catalog: 9033525 (Lot serial: all); Model Catalog: 9033519 9033520 9033521 (Lot serial: all); Model Catalog: 9033515 9033516 9033518 (Lot serial: all); Model Catalog: 9033512 9033513 9033514 (Lot serial: all)
  • Product Description
    Uni-Punch disposable biopsy punch
  • Manufacturer
    PREMIER DENTAL PRODUCTS COMPANY ALSO DBA PREMIER MEDICAL

Manufacturer

PREMIER DENTAL PRODUCTS COMPANY ALSO DBA PREMIER MEDICAL
  • Manufacturer Address
    PLYMOUTH MEETING
  • Source
    HC