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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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 Class 2 Recall
Smith & Nephew
see related information
Date Posted August 22, 2011
Recall Status1 Open
Recall Number Z-3050-2011
Recall Event ID 59329
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument
Code Information Lot Numbers: 50342499, 50344799, 50347017, 50349339 50354170, 50357485, 50360691, 50360992 50367247, 50374544, 50375820, 50370949 50371944
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover, Massachusetts 01810-1031
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Albert A. Pytka
978-749-1073
Manufacturer Reason
for Recall
Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Smith & Nephew sent an Urgent - Product Recall Notification letter dated July 7, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the form included in the letter and return to Hoangthi.le@smith-nephew.com or fax to 508-261-3620. Each affiliate must then notify each facility affected by the recall. To return product and obtain credit or order replacement product customers should contact the Smith & Nephew Endoscopy Returns at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to, endo.andreturns@smith-nephew.com. For questions, contact Hoangthi by phone at 508-337-3731.
Quantity in Commerce 570 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Dubai, Finland, France, Germany, Greece, Hong Kong, India, Italy, Israel, Japan, Korea, Malaysia, Mexico, Netherland, Norway, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, and Venezuela
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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