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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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 Class 2 Device Recall Smith & Nephewsee related information
Date Initiated by FirmFebruary 19, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 28, 2006
Recall NumberZ-0706-04
Recall Event ID 28423
Product Classification Camera, Still, Endoscopic - Product Code FXM
ProductEndocoupler 18 MM F.L, Autoclavable Catalog Number: 7207905, 7207905S
Code Information 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 
FEI Number 3003604053
Recalling Firm/
Manufacturer		 Smith And Nephew, Inc. Endoscopy Division
150 Minuteman Rd
Andover MA 01810-1031
For Additional Information Contact
614-624-3688
Manufacturer Reason
for Recall		Endocouplers assembled with screws that cannot be effectively sterilized
FDA Determined
Cause 2		Other
ActionSmith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.
Quantity in Commerce102 units
DistributionAL, 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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