Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Tandem Unipolar

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor 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
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.
-
-