Class 2 Device Recall Smith & Nephew Dyonics Saw Blade

• Date Initiated by Firm: February 02, 2017
• Create Date: February 22, 2017
• Recall Status: Terminated on September 20, 2019
• Recall Number: Z-1243-2017
• Recall Event ID: 76414
• Product Classification: Saw, powered, and accessories - Product Code HAB
• Product: Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
• Code Information: Batch Numbers: 50525150 50386077 50261802 50197616 50178740 50171398 50158656 50138050 50121538 50103379 50089298 50082582 50061131
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• Manufacturer Reason for Recall: The single use devices are provided sterile and do not have an expiration date on the label.
• FDA Determined Cause: Labeling Change Control
• Action: Smith & Nephew, Inc. initiated recall by letter on 2/2/17 advising of the problem, requesting inspection of inventory and return of product. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return.
• Quantity in Commerce: 3462
• Distribution: Nationwide Foreign: Brazil, Canada, Chile , China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, Venezuela
• 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.