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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 Stemsee related information
Date Initiated by FirmJanuary 22, 2009
Date PostedAugust 23, 2009
Recall Status1 Terminated 3 on February 07, 2012
Recall NumberZ-1819-2009
Recall Event ID 52582
510(K)NumberK043440 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductLEGION 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 ContactVictor Rocha
901-399-6771
Manufacturer Reason
for Recall		Products were mispackaged.
FDA Determined
Cause 2		Process control
ActionAll 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 Commerce16 units
DistributionWorldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
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.
510(K) Database510(K)s with Product Code = JWH
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