Events

Recall of COLLAGUIDE COLLAGEN MEMBRANE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by KENSEY NASH CORPORATION D.B.A. DSM BIOMEDICAL.

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
    66967
  • Event Risk Class
    I
  • Event Initiated Date
    2012-03-30
  • 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
    It was discovered that the devices were not placed in the validated load configuration during their sterilization cycles.

Device

COLLAGUIDE COLLAGEN MEMBRANE
  • Model / Serial
    Model Catalog: 20650-03 (Lot serial: >10 UNITS CONTACT THE MFG); Model Catalog: 20650-02 (Lot serial: >10 UNITS CONTACT THE MFG); Model Catalog: 20650-01 (Lot serial: >10 UNITS CONTACT THE MFG)
  • Product Description
    COLLAGEN DENTAL MEMBRANE RECALL
  • Manufacturer
    KENSEY NASH CORPORATION D.B.A. DSM BIOMEDICAL

Manufacturer

KENSEY NASH CORPORATION D.B.A. DSM BIOMEDICAL
  • Manufacturer Address
    EXTON
  • Manufacturer Parent Company (2017)
    Royal DSM NV
  • Source
    HC