Events

Recall of Device Recall Multipolar

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
    63122
  • Event Risk Class
    Class 2
  • Event Number
    Z-0410-2013
  • Event Initiated Date
    2012-08-31
  • Event Date Posted
    2012-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112642
  • 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, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
  • Reason
    Zimmer inc. is initiating a removal of the multipolar¿ bipolar cup liner 22 mm j.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
  • Action
    Zimmer sent an Urgent Medical Device Recall letter to all affected consignees during the week of September 3, 2012. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, quarantine the recalled product and return remaining inventory. Customers were advised to complete Inventory Return Certification form attached.

Device

Device Recall Multipolar
  • Model / Serial
    Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA nationwide including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea.
  • Product Description
    Multipolar¿ Bipolar Cup Liner 22 mm LD.; || Item 00-5001-040-22 || Product Usage: || The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00
  • 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