Events

Recall of Device Recall NK Flex Pin Guides

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
    61699
  • Event Risk Class
    Class 2
  • Event Number
    Z-1544-2012
  • Event Initiated Date
    2012-03-23
  • Event Date Posted
    2012-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108753
  • 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
    March 23, 2012 a field representative reported patient specific --0242 l tibia guide case packaging contained a different patient specific ..-0864-r tibia guide. the two patient specific products had been switched in packaging. neither products had been delivered to the end user.
  • Action
    Materialise telephoned both field representatives on March 23, 2012 and confirmed recalled product mix-up. Materialise requested both cases be returned and replacements were provided. No affected product was received by the end user.

Device

Device Recall NK Flex Pin Guides
  • Model / Serial
    Lot 56529886, REF 005970-000-03 Exp 2012-09-08
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of Ohio and Minnesota.
  • Product Description
    PATIENT SPECIFIC INSTRUMENTS || N-K FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
  • 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