Events

Recall of Medacta

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

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
    71121
  • Event Risk Class
    Class 2
  • Event Number
    Z-0275-2016
  • Event Initiated Date
    2015-04-17
  • Event Date Posted
    2015-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136166
  • 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
    Incorrect parts: packages of the gmk hinge tibial augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
  • Action
    On 4/16/15 all distributors with recalled product were immediately notified of the recall by phone. On 4/20/15, all distributors were further notified of the recall via email. The URGENT MEDICAL DEVICE RECALL letter dated 4/17/2015 the firm described the initiation of a recall for regarding the GMK HINGE Tibial Augmentation Size 4-10mm Reference 02.09TA410 / Lot 145129. The firm provided the following recall actions to be performed: 1.Check your inventory for the device listed above. If you find it, IMMEDIATELY place it in quarantine and DO NOT use it in surgery. 2.If you have further distributed this device to other customers please notify me and initiate their return to Medacta USA. 3.We will provide you with an update on a replacement within the next few days. The firm also provided a contact for customers requiring additional information. Mike Loiterman Director of Regulatory, Quality and Compliance Medacta USA Phone: 312548-9971Fax: 312-546-6881MLoiterman@medacta.us.com

Device

Medacta
  • Model / Serial
    Lot: 145129
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
  • Product Description
    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
  • Manufacturer
    Medacta Usa

Manufacturer

Medacta Usa
  • Manufacturer Address
    Medacta Usa, 1556 W Carroll Ave, Chicago IL 60607-1012
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA