Events

Recall of Omnilife Science Apex Knee System Modular Tibia Augment

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
    62912
  • Event Risk Class
    Class 2
  • Event Number
    Z-2373-2012
  • Event Initiated Date
    2012-08-09
  • Event Date Posted
    2012-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112027
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The apex knee system modular tibia augment may breach the inner and outer sterile pouches, compromising the sterility.
  • Action
    Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.

Device

Omnilife Science Apex Knee System Modular Tibia Augment
  • Model / Serial
    Lot Numbers: 8395,8823, 8929, 8969, 8984, 9166, 10319, 10740, 11703
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
  • Product Description
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm || Ref: KC-54040. || The Apex Knee System is intended for use as a primary or revision total knee replacement.
  • Manufacturer
    Omni Life Science

Manufacturer

Omni Life Science
  • Manufacturer Address
    Omni Life Science, 50 Oconnell Way, Unit 10, East Taunton MA 02718
  • Source
    USFDA