Events

Recall of Device Recall Apex ARC Hip Stem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Omnilife Science 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
    71407
  • Event Risk Class
    Class 2
  • Event Number
    Z-2064-2015
  • Event Initiated Date
    2015-06-03
  • Event Date Posted
    2015-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137697
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Product may breach the inner and outer sterile pouches during shipping or handling.
  • Action
    All product is consigned to US Agents until implanted or returned to OMNI. All US Agents holding the potentially affected inventory were notified that the product is being recalled via letter on June 3, 2015. The letter instructs them to immediately discontinue use of the product and contact OMNI Customer Service at 800-448-6664 to request a return materials authorization, and to return the Acknowledgement and Receipt form by FAX to 508-819-3390 or email to cflores@omnils.com.

Device

Device Recall Apex ARC Hip Stem
  • Model / Serial
    Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
  • Product Description
    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA || Product Usage: || The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
  • Manufacturer
    Omnilife Science Inc.

Manufacturer

Omnilife Science Inc.
  • Manufacturer Address
    Omnilife Science Inc., 50 Oconnell Way Ste 10, East Taunton MA 02718-1394
  • Manufacturer Parent Company (2017)
    Omnilife Science Inc
  • Source
    USFDA