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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 Unipolarsee related information
Date Initiated by FirmJanuary 12, 2009
Date PostedSeptember 24, 2009
Recall Status1 Terminated 3 on March 25, 2011
Recall NumberZ-2314-2009
Recall Event ID 52616
510(K)NumberK030766 
Product Classification Hip joint metal/polymer semi-constrained cemented prosthesis - Product Code LZY
ProductTandem 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/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information ContactVictor Rocha
901-399-6771
Manufacturer Reason
for Recall		46 mm Femoral head was mismarked and packaged as being 45 mm
FDA Determined
Cause 2		Process control
ActionAll 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 Commerce10 units
DistributionCA, FL, MI, and Canada
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 = LZY
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