Events

Recall of Device Recall APEX Hip System Bipolar Head

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Omni Life Science.

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
    52662
  • Event Risk Class
    Class 2
  • Event Number
    Z-1974-2009
  • Event Initiated Date
    2009-07-10
  • Event Date Posted
    2009-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83944
  • 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 Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
  • Reason
    The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
  • Action
    Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.

Device

Device Recall APEX Hip System Bipolar Head
  • Model / Serial
    Lot Number: 5149
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- Including states of AZ, CA, CO, FL, IL, MI, NJ, OK, UT, VA, and WI.
  • Product Description
    Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD || Product Code: H3-82846. || Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the hip.
  • Manufacturer
    Omni Life Science

Manufacturer

Omni Life Science
  • Manufacturer Address
    Omni Life Science, 175 Paramont Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Omnilife Science Inc
  • Source
    USFDA