Events

Recall of Device Recall Biomet Microplasty Cup Impactor

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
    46345
  • Event Risk Class
    Class 2
  • Event Number
    Z-1186-2008
  • Event Initiated Date
    2008-01-16
  • Event Date Posted
    2008-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67214
  • 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
    Instrument for hip prosthesis acetabular cup component. - Product Code LXH
  • Reason
    The weld at the lock location may fracture during impaction.
  • Action
    Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.

Device

Device Recall Biomet Microplasty Cup Impactor
  • Model / Serial
    Lot 095207.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.
  • Product Description
    Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46581-0587
  • Source
    USFDA