Events

Recall of Device Recall Materialise Distributed by Biomet Orthopedics, 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 N.V..

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
    70664
  • Event Risk Class
    Class 2
  • Event Number
    Z-1287-2015
  • Event Initiated Date
    2015-02-04
  • Event Date Posted
    2015-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134364
  • 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
    Images belonging to a different patient were used for the production of the patient specific surgical guide. the incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
  • Action
    Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.

Device

Device Recall Materialise Distributed by Biomet Orthopedics, Signature Personalized Patient Care...
  • Model / Serial
    Lot# 124471
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to the Netherlands only.
  • Product Description
    Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) || The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
  • Manufacturer
    Materialise N.V.

Manufacturer

Materialise N.V.
  • Manufacturer Address
    Materialise N.V., 15 Technologielaan, Heverlee Belgium
  • Manufacturer Parent Company (2017)
    Materialise Nv
  • Source
    USFDA