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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION Pressfit Stem

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  Class 2 Device Recall LEGION Pressfit Stem see related information
Date Initiated by Firm January 22, 2009
Date Posted August 23, 2009
Recall Status1 Terminated 3 on February 07, 2012
Recall Number Z-1819-2009
Recall Event ID 52582
510(K)Number K043440  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116.

The device is used for Orthopedic Knee Implants.
Code Information Lot Number: 06DAB0023.
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall		 Products were mispackaged.
FDA Determined
Cause 2		 Process control
Action All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.
Quantity in Commerce 16 units
Distribution Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
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 = JWH and Original Applicant = SMITH & NEPHEW, INC.
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