Events

Recall of Device Recall CONSERVE, TOTAL ACLASS Femoral Head

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
    52217
  • Event Risk Class
    Class 2
  • Event Number
    Z-1715-2009
  • Event Initiated Date
    2009-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82543
  • 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 cemented acetabular component) - Product Code JDL
  • Reason
    Incorrect packaging, swapped sizes.
  • Action
    Wright Medical Technology, Inc. notified hospitals, surgeons and their distributors of the recall situation via an "Urgent: Medical Device Voluntary Recall" notice dated May 14, 2009 explaining the problem, the hazard involved and requesting confirmation that the product was removed from their inventory. The letter included a "Fax Back" response page to ensure the receipt of the notice. For further questions, contact Wright Medical Technologies, Inc. at 1-800-874-5630.

Device

Device Recall CONSERVE, TOTAL ACLASS Femoral Head
  • Model / Serial
    Lot Number: 029798201.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- Including states of NC, TN, IA, IN, MD, WI, WV, OK, WA, PA, TN, TX, FL and CA and country of Canada.
  • Product Description
    CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. || The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA