Events

Recall of Device Recall Apex Knee System

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
    79268
  • Event Risk Class
    Class 2
  • Event Number
    Z-1117-2018
  • Event Initiated Date
    2017-11-20
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161796
  • 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 tibial baseplate identified has an improper expiration date marked on the external packaging. the improper expiration date (2202-03) is marked on the external packaging only. the correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
  • Action
    OMNIlife science, Inc. sent an Urgent Medical Device Advisory Notice dated November 20, 2017. Actions to be taken by the Customer/User "Immediately quarantine lot 26519 for KC-2206L "Return Product Using RMA# XXXX to OMNI. "This advisory notice only includes LOT 26519. It does not affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form and accompanying by FAX to 508-819-3390 or my email to CS@omnils.com. For further questions, please call (508) 824-2444.

Device

Device Recall Apex Knee System
  • Model / Serial
    Product Code KC-2206L, Lot # 26519
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and to the country Spain.
  • Product Description
    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L || The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.
  • Manufacturer
    OMNIlife science Inc.

Manufacturer

OMNIlife science Inc.
  • Manufacturer Address
    OMNIlife science Inc., 480 Paramount Dr, Raynham MA 02767-1085
  • Manufacturer Parent Company (2017)
    Omnilife Science Inc
  • Source
    USFDA