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Class 2 Device Recall Smith & Nephew |
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Date Initiated by Firm |
July 07, 2011 |
Date Posted |
August 22, 2011 |
Recall Status1 |
Terminated 3 on July 23, 2015 |
Recall Number |
Z-3050-2011 |
Recall Event ID |
59329 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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 MA 01810-1031
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For Additional Information Contact |
Albert A. Pytka 978-749-1073
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Manufacturer Reason for Recall |
Shaft tip (casting) does not meet the SNE 416
specification, which could result in rusting of the Tendon Strippers
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FDA Determined Cause 2 |
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
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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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