Events

Recall of Device Recall APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells

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
    71461
  • Event Risk Class
    Class 2
  • Event Number
    Z-2445-2015
  • Event Initiated Date
    2015-06-04
  • Event Date Posted
    2015-08-21
  • 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=137883
  • 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/polymer, porous uncemented - Product Code LPH
  • Reason
    The device may have improper screw hole placement due to inaccurate location of the index line.
  • Action
    Omni sent an Urgent Medical Device Field Correction letter dated June 4, 2015 via email to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory for affected product and complete and return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.

Device

Device Recall APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells
  • Model / Serial
    H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
  • Product Description
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. || Product Usage: || The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
  • 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