Events

Recall of Device Recall Exactech Biolox

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Exactech, 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
    45859
  • Event Risk Class
    Class 3
  • Event Number
    Z-0572-2008
  • Event Initiated Date
    2007-11-01
  • Event Date Posted
    2008-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66433
  • 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
    Hip Prosthesis Femoral Head - Product Code LPH
  • Reason
    Mislabeled: a ten piece lot of 140-32-03, 12/14 bioloxforte alumina femoral heads 32mm (1069020 - 1069029), from ceramtec were incorrectly labeled as 140-28-03 12/14 bioloxforte alumina femoral heads, 28mm.
  • Action
    Exactech issued a recall letter, titled Important Product Recall Notice on 10/31/2007 to the Distibutors that received the recalled product. It requested that all device recipients be notified and all product be returned to the firm.

Device

Device Recall Exactech Biolox
  • Model / Serial
    Lot Number: 474042
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to NY, OH and TN.
  • Product Description
    Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA