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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 & Nephewsee related information
Date Initiated by FirmMay 06, 2011
Date PostedJuly 01, 2011
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-2731-2011
Recall Event ID 58733
Product Classification Saw, powered, and accessories - Product Code HAB
ProductDYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
Code Information Lot Number: 50540107
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information ContactSAME
978-749-1073
Manufacturer Reason
for Recall		Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
FDA Determined
Cause 2		Process control
ActionSmith & Nephew notified customers by an "URGENT - PRODUCT RECALL 1st NOTIFICATION" letter dated May 6, 2011. The letter describes the product, problem, and actions to be taken. The letter asked customers to call 800-343-5717 (option 3) or send an email to endo.andreturn@smith-nephew.com for a Return Authorization (RA) Number to return product, obtain credit or order replacement blades. Customers are to complete the form and return to the address provided being sure to reference the RA number. For any questions regarding this recall customers were instructed to call 508-337-3731.
Quantity in Commerce744 units
DistributionWorldwide Distribution -- USA (nationwide) and countries of: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, Turkey, and United Kingdom.
Total Product Life CycleTPLC 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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