Events

Recall of Device Recall Depuy DELTA Xtend

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Depuy Orthopaedics, 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
    49112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0535-2009
  • Event Initiated Date
    2008-07-10
  • Event Date Posted
    2009-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72784
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.
  • Action
    A letter, "Urgent Device Correction" dated July 8, 2008 was sent via certified mail to implanting surgeons advising them of the issues and guidance on how to mitigate the problem. A communication was also sent to all sales representatives and territory offices on July 15, 2008. For questions, please contact Depuy Orthopaedics, Inc. Customer Service at 1-800-473-3789.

Device

Device Recall Depuy DELTA Xtend
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. || The device is used as a shoulder implant.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Manufacturer Address
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA