Events

Recall of Device Recall Cylindrical Reamer

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
    57605
  • Event Risk Class
    Class 2
  • Event Number
    Z-1530-2011
  • Event Initiated Date
    2010-12-23
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96761
  • 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
    The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. testing found that if the cutting edge is missing, the reamer will not perform as intended.
  • Action
    The firm, BIOMET, sent an" URGENT MEDICAL DEVICE RECALL NOTICE" dated December 23, 2010 to its customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to immediately locate, discontinue use of product and return the product to Biomet. Biomet distributors were told to notify hospital personnel of the recall if they had distributed the product to hospital customers. The Customers/Distributors were instructed to confirm receipt of the notice by calling 800-348-9500 extension 3755 and 3983 and to complete and return the Response Form included with the recall notice via fax to 574-372-1683. Questions related to this notice should be directed to 574-371-3755 or 574-372-3983, Monday through Friday, 8am to 5pm.

Device

Device Recall Cylindrical Reamer
  • Model / Serial
    039240 and 096550.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • Product Description
    Cylindrical Bullet Nose Reamer 8.5 mm x 250 mm, REF 475805, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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