Events

Recall of Device Recall Signature Personalized Patient Care System

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
    74213
  • Event Risk Class
    Class 2
  • Event Number
    Z-1941-2016
  • Event Initiated Date
    2016-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146807
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    A patient specific case of signature personalized patient care system knee guides included a femur guide which does not match the patient associated with the case. if the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
  • Action
    Materialise sent an URGENT: Signature Personalized Patient Care System Knee Guides Notification dated May 3, 2016. It was sent to the affected customer via email with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Contact Materialise customer service for additional information or to find a status of the second patient specific surgical guide Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.734-259-7016

Device

Device Recall Signature Personalized Patient Care System
  • Model / Serial
    Lot #154970
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    One consignee, Indiana.
  • Product Description
    Signature TKA GDE/MDL Set 04-05 || Patient-specific surgical guide and instrument set.
  • 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