Events

Recall of CALSTRUX BONE VOID FILLER

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

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
    24619
  • Event Risk Class
    II
  • Event Initiated Date
    2006-08-08
  • 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
    Calstrux used in combination with other products has resulted in a trend in adverse event reports including localized induration swelling inflammation wound drainage infection and device migration.

Device

CALSTRUX BONE VOID FILLER
  • Model / Serial
    Model Catalog: 400-05CN (Lot serial: TCDN004); Model Catalog: 400-15CN (Lot serial: TCFM001); Model Catalog: 400-10CN (Lot serial: TCFM001); Model Catalog: 400-05CN (Lot serial: TCFM001); Model Catalog: 400-15CN (Lot serial: TCCN003); Model Catalog: 400-10CN (Lot serial: TCCN003); Model Catalog: 400-05CN (Lot serial: TCCN003); Model Catalog: 400-15CN (Lot serial: TCKM002); Model Catalog: 400-10CN (Lot serial: TCKM002); Model Catalog: 400-05CN (Lot serial: TCKM002); Model Catalog: 400-15CN (Lot serial: TCBN002); Model Catalog: 400-10CN (Lot serial: TCBN002); Model Catalog: 400-05CN (Lot serial: TCBN002); Model Catalog: 400-10CN (Lot serial: TCDN004); Model Catalog: 400-15CN (Lot serial: TCDN004); Model Catalog: 400-05CN (Lot serial: TCBN001); Model Catalog: 400-15CN (Lot serial: TCBN001); Model Catalog: 400-10CN (Lot serial: TCBN001)
  • Product Description
    Calstrux
  • Manufacturer
    OLYMPUS BIOTECH CORPORATION

Manufacturer

OLYMPUS BIOTECH CORPORATION
  • Manufacturer Address
    HOPKINTON
  • Source
    HC