Events

Recall of Device Recall Smith & Nephew Hip Arthroscopy Repair Instrument Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc. Endoscopy Division.

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
    58894
  • Event Risk Class
    Class 2
  • Event Number
    Z-2646-2011
  • Event Initiated Date
    2011-05-19
  • Event Date Posted
    2011-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100485
  • 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
    Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
  • Reason
    Hip arthroscopy repair instrument tray shipped with an incorrect instructions for use (ifu).
  • Action
    Smith & Nephew sent an "URGENT FIELD CORRECTION NOTIFICATION" letter dated May 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to confirm receipt of the corrected IFU document (10600729 rev B.) and communicate to appropriate facility individuals. Once appropriate individuals are informed, customers were instructed to complete and return information requested at the bottom of the letter. The completed information should be returned to Smith& Nephew via fax at 978-749-1654 or by mail at Smith & Nephew Endoscopy, 150 Minuteman Road, Andover, MA 01810. Questions may be answered by contacting the Manager, QA and Compliance at 978-749-1397.

Device

Device Recall Smith & Nephew Hip Arthroscopy Repair Instrument Tray
  • Model / Serial
    Lot Number: 48208-1-1B
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and Venezuela.
  • Product Description
    Smith & Nephew Hip Arthroscopy Repair Instrument Tray || Part Number: 72202732 || Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated stainless steel case with a latchable lid and handle. The tray is fitted with nylon coated aluminum holders, silicone instrument holders, and a protective mat. The instrument tray is marked to facilitate organized instrument placement.
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • Manufacturer Address
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA