Events

Recall of Transcend Hip System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology 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
    26948
  • Event Risk Class
    Class 2
  • Event Number
    Z-1186-03
  • Event Initiated Date
    2003-08-18
  • Event Date Posted
    2003-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28846
  • 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/Ceramic/Metal, Cemented Or Uncemented - Product Code MRA
  • Reason
    Wright medical commercially distributed transcend alumina acetabular shell liners lacking the required process validation.
  • Action
    Distributors returned thier stock after May 8, 2003

Device

Transcend Hip System
  • Model / Serial
    Part No. Lot Serial No. 73003258 070A122950 71002846 101A147607 72003252 101A147579 71002846 01214750 73003258 020A116075 73003258 101A147616 71002846 101A147609 71002846 01214749 72003252 01214581 72003252 01215268 73003258 101A147617 73003258 01214576 74003664 101A147618 72003252 101A147580 71002846 048A080430 72003252 0124580 71002846 01214751 74003664 061A136523 72003252 119A112057 73003258 01214575 71002846 031A139399 72003252 101A147577 72003252 01214582 72003252 101A147578 71002846 039A100609 72003252 081A145884
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    nationwide
  • Product Description
    Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Rd, P.O. Box 100, Arlington TN 38002
  • Source
    USFDA