Events

Recall of Device Recall APEX (OMNIlife Science, Inc.)

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
    71470
  • Event Risk Class
    Class 2
  • Event Number
    Z-2455-2015
  • Event Initiated Date
    2015-06-09
  • Event Date Posted
    2015-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137912
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Reason
    The markings on both versions of the offset femoral alignment guides are incorrect. specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
  • Action
    Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.

Device

Device Recall APEX (OMNIlife Science, Inc.)
  • Model / Serial
    Lot Numbers: MM0314R, VA0713, Z1111
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
  • Product Description
    Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 || Product Usage: || The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. || Product Usage: || The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
  • 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