Events

Recall of Device Recall Smith & Nephew

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith And 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
    28423
  • Event Risk Class
    Class 2
  • Event Number
    Z-0706-04
  • Event Initiated Date
    2004-02-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31840
  • 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
    Camera, Still, Endoscopic - Product Code FXM
  • Reason
    Endocouplers assembled with screws that cannot be effectively sterilized.
  • Action
    Smith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.

Device

Device Recall Smith & Nephew
  • Model / Serial
    Part No: 7207095 XF 819 XF 922 XF 951 XF 955 XF 960 XF 962 XF 963 XF 967 XF 968 XF 990 XF 1033 XF 974 XF 976 XF 952 XF 835 XF 878 XF 1012 XF 1013 XF 1017 XF 1029 XF 1036 XF 1039 XF 1042 XF 811 XF 817 XF 820 XF 920 XF 965 XF 971 XF 977 XF 980 XF 988 XF 991 XF 992 XF 996 XF 1002 XF 1004 XF 1020 XF 1025 XF 1026 XF 1030 XF 1032 XF 1045 XF 1046 XF 957 XF 203  XF 704 XF 954 XF 959 XF 969 XF 970 XF 987 XF 1001 XF 801 XF 816 XF 712 XF 301 XF 909 XF 917 XF 848 XF 863 XF 864 XF 894 XF 904 XF 910 XF 918 XF 865 XF 868 XF 829 XF 800 XF 806 XF 888 XF 892 XF 953 XF 964 XF 966 XF 851 XF 858 XF 879 XF 807 XF 808 XF 897 XF 925 XF 935 XF 956 XF 958 XF 961 XF 716 XF 818 XF 994 XF 1009 XF 1037  Part No: 7207905S  Serial #s: XF 144  XF 456  XF 709  XF 779  XF 884  XF 699  XF 748  XF 529  XF 669  XF 850
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CT, PA, MA, ME, MI, MO, NC, NH, NJ, NY, OH, UT , TN, TX, VT, WA Foreiing:Australia, Canada, China, Brazil, France, Germany, Greece, India, Italy, Japan.Korea, Netherlands, Norway, Portugal, South Africa, Spain, Turkey, UK
  • Product Description
    Endocoupler 18 MM F.L, Autoclavable || Catalog Number: 7207905, 7207905S
  • Manufacturer
    Smith And Nephew, Inc. Endoscopy Division

Manufacturer

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