Events

Recall of Device Recall Modular Microplasty Cup inserter 3/8" thread

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
    56591
  • Event Risk Class
    Class 2
  • Event Number
    Z-2504-2010
  • Event Initiated Date
    2010-07-28
  • Event Date Posted
    2010-09-25
  • 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=94040
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of "music wire" the recalling frim conducted tests to determine the effects of theis change in materials. the testing showed that the wire would oxidize and there would be early failure of the device.
  • Action
    The firm send URGENT MEDICAL DEVICE RECALL NOTICES to its distributors on 7/28/2010. The notices instructed the distributors to discontinue use of the product and return it to Biomet.

Device

Device Recall Modular Microplasty Cup inserter 3/8" thread
  • Model / Serial
    658180, 658190 and 907630.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Australia, Canada, Mexico, Chile, Japan.
  • Product Description
    Modular Microplasty Cup inserter 3/8" thread , REF 31-400600
  • 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