Events

Recall of Device Recall Signature

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
    67039
  • Event Risk Class
    Class 2
  • Event Number
    Z-0628-2014
  • Event Initiated Date
    2013-11-26
  • Event Date Posted
    2014-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124626
  • 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, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
  • Reason
    Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
  • Action
    Materialise USA LLC notified the Field Representative on November 26, 2013 of the recall by phone followed by E-mail notification. The notification identified the device and reason for the recall. Notification directions included instructions to find and quarantine the device and return it Materialise. A replacement device was shipped November 27, 2013 receiving the defective device was called, followed by E-mail notification the Recall, which identified the device, problem, and instructed the distributor to find and quarantine product. For questions regarding this recall call 734-662-5057.

Device

Device Recall Signature
  • Model / Serial
    Lot 094929
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution: MO only.
  • Product Description
    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE || SIGNATURE || M PKA GDE/MDL SET SML-MP || DD.....R-FEB55RKA-T JA-A01 05551 || PKA POST CUT SML-PKA MICROPLASTY || CUSTOM-MADE DEVICE || non-sterile || The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
  • 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