Events

Recall of Device Recall Profemur R, Revision Hip system, Proximal Body (part),

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
    37826
  • Event Risk Class
    Class 2
  • Event Number
    Z-0867-2007
  • Event Initiated Date
    2007-03-27
  • Event Date Posted
    2007-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51725
  • 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
    hip prosthesis - Product Code LZO
  • Reason
    The titanium plasma coating was found to have missing fragments.
  • Action
    The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.

Device

Device Recall Profemur R, Revision Hip system, Proximal Body (part),
  • Model / Serial
    Lot Nos.: W09356957, W09358977
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Puerto Rico, & Japan
  • Product Description
    Profemur¿ R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant.
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Road, PO Box 100, Arlington TN 38002-0100
  • Source
    USFDA