Events

Recall of CPT Modular Stem

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
    63124
  • Event Risk Class
    Class 2
  • Event Number
    Z-0061-2013
  • Event Initiated Date
    2012-09-13
  • Event Date Posted
    2012-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112644
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Zimmer inc. is initiating a removal of the cpt modular stem (item 00-8011-001-00), cpt stem petite (item 00-8011-000-05; ) and cpt femoral stem 12/14 neck taper extended offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. zimmer received five complaints of this packaging issue.
  • Action
    Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.

Device

CPT Modular Stem
  • Model / Serial
    Lot 62017554
  • Product Classification
    Orthopedic Devices
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
  • Product Description
    CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. || CPT stems are primary cemented femoral hip stems used by surgeons in 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