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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew Hip Arthroscopy Repair Instrument Tray

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  Class 2 Device Recall Smith & Nephew Hip Arthroscopy Repair Instrument Tray see related information
Date Initiated by Firm May 19, 2011
Date Posted June 24, 2011
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-2646-2011
Recall Event ID 58894
510(K)Number K102544  
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product Smith & Nephew Hip Arthroscopy Repair Instrument Tray
Part Number: 72202732

Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated stainless steel case with a latchable lid and handle. The tray is fitted with nylon coated aluminum holders, silicone instrument holders, and a protective mat. The instrument tray is marked to facilitate organized instrument placement.
Code Information Lot Number: 48208-1-1B
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact SAME
978-749-1073
Manufacturer Reason
for Recall		 Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)
FDA Determined
Cause 2		 Labeling mix-ups
Action Smith & Nephew sent an "URGENT FIELD CORRECTION NOTIFICATION" letter dated May 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to confirm receipt of the corrected IFU document (10600729 rev B.) and communicate to appropriate facility individuals. Once appropriate individuals are informed, customers were instructed to complete and return information requested at the bottom of the letter. The completed information should be returned to Smith& Nephew via fax at 978-749-1654 or by mail at Smith & Nephew Endoscopy, 150 Minuteman Road, Andover, MA 01810. Questions may be answered by contacting the Manager, QA and Compliance at 978-749-1397.
Quantity in Commerce 11 units
Distribution Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and 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.
510(K) Database 510(K)s with Product Code = KCT and Original Applicant = SMITH & NEPHEW INC., ENDOSCOPY DIV.
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