Events

Recall of Device Recall Smith & Nephew ACUFEX RapPac ACL Accessory Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, 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
    25082
  • Event Risk Class
    Class 2
  • Event Number
    Z-0413-03
  • Event Initiated Date
    2002-11-08
  • Event Date Posted
    2003-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25125
  • 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
    Arthroscope - Product Code HRX
  • Reason
    Potential for non sterility as package tray does not contain aeration holes for eto processing.
  • Action
    Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.

Device

Device Recall Smith & Nephew ACUFEX RapPac ACL Accessory Kit
  • Model / Serial
    Lot Number: 552240
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,
  • Product Description
    Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile || Catalog Number: 014725
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 130 Forbes Boulevard, Mansfield MA 02048
  • Source
    USFDA