Class 2 Device Recall Smith & Nephew

• Date Initiated by Firm: March 01, 2007
• Date Posted: April 07, 2007
• Recall Status: Terminated on July 14, 2008
• Recall Number: Z-0726-2007
• Recall Event ID: 37582
• Product Classification: Suture - Product Code NBW
• Product: Smith & Nephew Suture Passer 2 inch Part Number : 7209167
• Code Information: All lot codes
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc. Endoscopy Division; 150 Minuteman Drive; Andover MA 01810-1031
• For Additional Information Contact: Jason Bilobram; 978-474-6332
• Manufacturer Reason for Recall: Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
• FDA Determined Cause: Other
• Action: Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
• Quantity in Commerce: 12, 292 units for all recalls Z-0724-0726-07
• Distribution: World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway
• 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.