Events

Recall of Signature Patient Specific Surgical Guides

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
    72425
  • Event Risk Class
    Class 2
  • Event Number
    Z-0162-2016
  • Event Date Posted
    2015-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141084
  • 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
    Patient specific manual orthopedic stereotaxic system - Product Code OSF
  • Reason
    Potential inaccuracies in the alignment of the guides. surgery was inaccurately planned because the patient image data was incorrectly processed.
  • Action
    On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was followed up by e-mail notification letter with response forms. Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be Customer Service Materialise USA LLC 44650 Helm Court Plymouth, Michigan 48170 734-259-7033

Device

Signature Patient Specific Surgical Guides
  • Model / Serial
    42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial  42422461 139540 2016-02-17  42-422551 1 391 51 2016-01-14  42422551 1 38805 2016-02-03  42-422551 140787 2016-03-03
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in MI, ID, TX, and in France.
  • Product Description
    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
  • 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