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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew Dyonics Saw Blade

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  Class 2 Device Recall Smith & Nephew Dyonics Saw Blade see related information
Date Initiated by Firm February 02, 2017
Create Date February 22, 2017
Recall Status1 Terminated 3 on September 20, 2019
Recall Number Z-1240-2017
Recall Event ID 76414
Product Classification Saw, powered, and accessories - Product Code HAB
Product Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702

Code Information Batch Numbers: 50525150 50386077 50261802 50197616 50178740 50171398 50158656 50138050 50121538 50103379 50089298 50082582 50061131
Recalling Firm/
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 2
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 2496
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.