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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 Recall
LEGION Pressfit Stem
see related information
Date Posted August 23, 2009
Recall Status1 Open
Recall Number Z-1820-2009
Recall Event ID 52582
Premarket Notification
510(K) Number
K043440 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
Code Information Lot Number: 06DM08612.
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall
Products were mispackaged.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 19 units
Distribution Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = SMITH & NEPHEW, INC.
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