Events

Recall of Device Recall Depuy Preservation UniCompartmental Knee

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
    36849
  • Event Risk Class
    Class 2
  • Event Number
    Z-0458-2007
  • Event Initiated Date
    2006-11-15
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49629
  • 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
    Tibal Trays - Product Code HRY
  • Reason
    Chamfer step defect-the surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a chamfer step defect.
  • Action
    The firm's sales force was notified of the recall via email sent 11/15/06. The sales force was instructed to deliver a recall letter to personnel in those facilities that had purchased the products, and the recall letters instruct the facilities to quarantine the product and respond to Depuy concerning product returns. The sales force was provided with a Dear Doctor letter for issuance to implanting surgeons at the sales forces' discretion. The recall was extended to Sizes 1-5 on Dec 5, 2006 with a second recall letter.

Device

Device Recall Depuy Preservation UniCompartmental Knee
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Class II Recall - Worldwide Distribution ---USA and countries of Argentina and Colombia.
  • Product Description
    Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/left Lateral, Size 5, sterile; Part number 1498-23-005.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

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