Events

Recall of Device Recall Persona Cemented Tibial Broach Inserter/Extractor

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
    69906
  • Event Risk Class
    Class 2
  • Event Number
    Z-0853-2015
  • Event Initiated Date
    2014-12-04
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131934
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. zimmer received one complaint indicating the magnet cover of a persona cemented tibial broach inserter/extractor handle lot 62085420 was missing after broaching the tibia. postoperative radiographs were inspected and the magnet cover was not identified. the investigation indi.
  • Action
    Notifications will be sent to the affected distributors and hospital risk managers with instructions for returning the affected product the week of December 8, 2014. Recalled product will be quarantined and returned to Zimmer Sales Representatives to be destroyed. The public contact for the recall is: Consumer Relations Call Center Zimmer, Inc. P O Box 708 Warsaw, IN 46581-0708 consumer@zimmer.com Phone: 1-800-447-5633 Fax: 574-371-8755

Device

Device Recall Persona Cemented Tibial Broach Inserter/Extractor
  • Model / Serial
    Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
  • Product Description
    Persona Cemented Tibial Broach Inserter/Extractor. || The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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