Events

Recall of STERILE DISPOSABLE SKULL PINS FOR ADULTS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PRO MED INSTRUMENTS GMBH.

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
    124583
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-27
  • 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
    We became aware of two breakages of the pin tips. we cannot exclude a user error or that irregularities in the manufacturing process of the metal component of the product might have contributed to the described events. we decided to conduct this voluntary recall in order to ensure patient safety.

Device

STERILE DISPOSABLE SKULL PINS FOR ADULTS
  • Model / Serial
    Model Catalog: 3006-00 (Lot serial: Lot 17072); Model Catalog: 3006-00 (Lot serial: Lot 17041)
  • Product Description
    DORO Sterile Disposable Skull Pins Stainless Steel Adult
  • Manufacturer
    PRO MED INSTRUMENTS GMBH

Manufacturer

PRO MED INSTRUMENTS GMBH