Events

Recall of Device Recall Biomet Graft Preparation System

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
    38116
  • Event Risk Class
    Class 3
  • Event Number
    Z-0993-2007
  • Event Initiated Date
    2007-06-11
  • Event Date Posted
    2007-07-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52981
  • 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
    bone graft preparation syringe - Product Code FMF
  • Reason
    The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
  • Action
    Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.

Device

Device Recall Biomet Graft Preparation System
  • Model / Serial
    Lots 192180, exp. Jan 2012; 223260, exp. Jan 2012 and 652330, exp May 2011.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Chile, Italy, Spain and United Kingdom.
  • Product Description
    Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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