Events

Recall of Orthopedic Manual surgical instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, 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
    69280
  • Event Risk Class
    Class 2
  • Event Number
    Z-0021-2015
  • Event Initiated Date
    2014-09-17
  • Event Date Posted
    2014-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130153
  • 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
    Reamer - Product Code HTO
  • Reason
    Investigation determined that units supplied were missing the 4x21 degree helix angle.
  • Action
    On September 17, 2014, "URGENT MEDICAL DEVICE RECALL NOTICE" was sent to the consignee Biomet Global Supply Chain Center (GSCC) by email and FedEx. GSCC notified all of the customers within Europe, the Middle East, and Asia that received the affected product. The recall notification included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call (574) 372-1570.

Device

Orthopedic Manual surgical instrument
  • Model / Serial
    Catalog numbers: 32-481000  Lot Numbers: 615860, 765230  Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
  • Product Description
    Compress Face Reamer || Product Usage: || Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46581
  • 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