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
    22960
  • Event Risk Class
    II
  • Event Initiated Date
    2012-12-03
  • 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 device uni-punch disposable biopsy punch for which premier is identified as the manufacturer.

Device

UNI-PUNCH DISPOSABLE BIOPSY PUNCH
  • Model / Serial
    Model Catalog: 903352190335139033520 (Lot serial: ALL LOTS); Model Catalog: 903352590335199033512 (Lot serial: ALL LOTS); Model Catalog: 903350390335109033504 (Lot serial: ALL LOTS); Model Catalog: 903350990335029033511 (Lot serial: ALL LOTS); Model Catalog: 903351490335159033516 (Lot serial: ALL LOTS); Model Catalog: 9033518 (Lot serial: ALL LOTS); Model Catalog: 903350590335069033508 (Lot serial: ALL LOTS)
  • 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