Class 2 Device Recall Smith & Nephew

• Date Initiated by Firm: February 19, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 28, 2006
• Recall Number: Z-0705-04
• Recall Event ID: 28423
• Product Classification: Camera, Still, Endoscopic - Product Code FXM
• Product: Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398
• Code Information: Serial #s: 50001621-2 50001621-1
• 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: 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: 2 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.