Events

Recall of Alloclassic

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
    63103
  • Event Risk Class
    Class 2
  • Event Number
    Z-0211-2013
  • Event Initiated Date
    2012-09-04
  • Event Date Posted
    2012-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113219
  • 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, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Zimmer inc., is initiating a correction to the patient labels of products manufactured before march 20i0 by the zimmer gmbh production site in winterthur, switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. while the information printed on the product label is correct, the info.
  • Action
    Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.

Device

Alloclassic
  • Model / Serial
    REF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Biolox¿ delta Ceramic Femoral Head || Rx only, sterile
  • 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