Events

Recall of Device Recall Medacta GMK HINGE, Tibial Insert Fixed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medacta Usa Inc.

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
    77467
  • Event Risk Class
    Class 2
  • Event Number
    Z-2661-2017
  • Event Initiated Date
    2017-05-19
  • Event Date Posted
    2017-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156092
  • 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, constrained, cemented, metal/polymer - Product Code KRO
  • Reason
    One lot of product does not include a screw for attachment to the tibial base plate.
  • Action
    On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone.

Device

Device Recall Medacta GMK HINGE, Tibial Insert Fixed
  • Model / Serial
    Lot # 163646
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CA, AZ, NC, Israel, France
  • Product Description
    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Manufacturer Address
    Medacta Usa Inc, 3973 Delp St, Memphis TN 38118-6110
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA