Events

Recall of Device Recall Apex Arc Hip Stem, Size 2, HA Coated

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
    68527
  • Event Risk Class
    Class 2
  • Event Number
    Z-2241-2014
  • Event Initiated Date
    2014-05-09
  • Event Date Posted
    2014-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128142
  • 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
    Staining on hip implant.
  • Action
    All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science.

Device

Device Recall Apex Arc Hip Stem, Size 2, HA Coated
  • Model / Serial
    Lot: 17284
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US: CA, OK, VA, FL, MA, NY, TX
  • Product Description
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-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