Events

Recall of MIS Slotted Femoral Head Provisional

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, 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
    63066
  • Event Risk Class
    Class 2
  • Event Number
    Z-0395-2013
  • Event Initiated Date
    2010-10-10
  • Event Date Posted
    2012-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114129
  • 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
    Template - Product Code HWT
  • Reason
    Surgical technique instructions for the versys and slotted provisional femoral heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. to reduce incidence of sub-optimal fit between provisional femoral heads and the mat.
  • Action
    The firm, Zimmer, sent notification by email to consignees beginning October 10, 2012 with a follow-up letter titled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete a spreadsheet of current users and contact information and immediately provide this information via email to: CorporateQuality.Postmarket@zimmer.com, and review and become familiar with the content and recommendations of the attached letter sent to the customers. For questions call 1-877-946-2761.

Device

MIS Slotted Femoral Head Provisional
  • Model / Serial
    All lots distributed from lot 69998600 (2/20/1996) to present
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
  • Product Description
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 || 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 || 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 || 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 || 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA