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U.S. Department of Health and Human Services

Class 2 Device Recall Tandem Unipolar

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  Class 2 Device Recall Tandem Unipolar see related information
Date Initiated by Firm January 12, 2009
Date Posted September 24, 2009
Recall Status1 Terminated 3 on March 25, 2011
Recall Number Z-2314-2009
Recall Event ID 52616
510(K)Number K030766  
Product Classification Hip joint metal/polymer semi-constrained cemented prosthesis - Product Code LZY
Product Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116

Designed for use with femoral stems and acetabular
components distributed by Smith & Nephew.
Code Information Lot Numbers: 08LM01326, 08LM01327, 08LM02210
Recalling Firm/
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor Rocha
Manufacturer Reason
for Recall
46 mm Femoral head was mismarked and packaged as being 45 mm
FDA Determined
Cause 2
Process control
Action All affected Smith & Nephew Sales Representatives were notified of problem and sent recall notice in overnight mail on 01/12/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/12/2009. They were instructed to immediately quarantine the product for return. The firm re-issued the letter on 04/06/2009 to address hazard to health. Contact Smith & Nephew, Inc at 1.901.399.6771 if there are any questions.
Quantity in Commerce 10 units
Distribution CA, FL, MI, and Canada
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 = LZY and Original Applicant = SMITH & NEPHEW, INC.