Events

Recall of Device Recall UJoint Hex Head Driver

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
    60722
  • Event Risk Class
    Class 2
  • Event Number
    Z-0740-2012
  • Event Initiated Date
    2011-12-19
  • Event Date Posted
    2012-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106309
  • 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
    Prothesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Tip of hex-head screwdriver may break off during use in hip replacement procedure.
  • Action
    Ortho Development Corporation sent an "URGENT!! DEVICE RECALL" letter dated December 19, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check to see if they have the affected device. Customers who have the device are to return the device to the firm, immediately. The firm will provide suitable replacements. Contact the Regulatory Affairs Manager for questions regarding this notice.

Device

Device Recall UJoint Hex Head Driver
  • Model / Serial
    Lot numbers 1365304, 1365305.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.
  • Product Description
    U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. || The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum.
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Manufacturer Parent Company (2017)
    Ortho Development Corporation
  • Source
    USFDA