Events

Recall of Device Recall Ortho Development Primaloc Cemented Hip System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho Development Corporation.

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
    56499
  • Event Risk Class
    Class 2
  • Event Number
    Z-0315-2011
  • Event Initiated Date
    2010-07-28
  • Event Date Posted
    2010-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93791
  • 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, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
  • Reason
    The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
  • Action
    Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.

Device

Device Recall Ortho Development Primaloc Cemented Hip System
  • Model / Serial
    Work order numbers: 0050794; 0051535; 0054967; 0055667; 0060372; 0061102; 0061769; 0062929; 0063395
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: Japan
  • Product Description
    Distal Centralizer 10 mm
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Manufacturer Parent Company (2017)
    Ortho Development Corporation
  • Source
    USFDA