Events

Recall of Device Recall ProPlan CMF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Materialise USA LLC.

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
    66935
  • Event Risk Class
    Class 2
  • Event Number
    Z-0578-2014
  • Event Initiated Date
    2013-11-08
  • Event Date Posted
    2013-12-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124272
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
  • Reason
    Patient specific guide contained the incorrect case report. the case report contains patient specific surgical plan information.
  • Action
    Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.

Device

Device Recall ProPlan CMF
  • Model / Serial
    Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
  • Distribution
    Distributed in Canada.
  • Product Description
    ProPlan CMF Guide(s) Model(s) || REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. || Used as surgical tools to transfer a pre-operative plan to surgery. || .
  • Manufacturer
    Materialise USA LLC

Manufacturer

Materialise USA LLC
  • Manufacturer Address
    Materialise USA LLC, 44650 Helm Ct, Plymouth MI 48170-6061
  • Manufacturer Parent Company (2017)
    Materialise Nv
  • Source
    USFDA