Events

Recall of OSTEOPOWER MODULAR HANDPIECE SYSTEM

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

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
    78953
  • Event Risk Class
    II
  • Event Initiated Date
    2001-10-23
  • 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
    Osteomed has experienced corrosion stress failure with a component within the assembly (450-0214-06) which may prevent the collet from locking in place.

Device

OSTEOPOWER MODULAR HANDPIECE SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: CAT # 450-0777); Model Catalog: (Lot serial: 011352 011855 011939 12079); Model Catalog: (Lot serial: 012080 012486 012487); Model Catalog: (Lot serial: DEV LIC # 8023)
  • Product Description
    1:1 straight drill/springlocking collet
  • Manufacturer
    OSTEOMED

Manufacturer

OSTEOMED
  • Manufacturer Address
    ADDISON
  • Source
    HC