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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 & Nephew see related information
Date Initiated by Firm February 19, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 28, 2006
Recall Number Z-0708-04
Recall Event ID 28423
Product Classification Camera, Still, Endoscopic - Product Code FXM
Product Endocpir, Zoom for Dyonics 3-Chip Camera
Catalog Number: 7205461
Code Information Part No: 7205461  Serial #s: UE 1130  UE 1234  UE 1142  UE 1127  UE 1143  UE 1212  UE 1216  UE 1222  UE 1226  UE 1217  UE 1145  UE 1227 
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
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.
Quantity in Commerce 102 units
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
Total Product Life Cycle TPLC 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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