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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Hip and Knee Replacement System

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  Class 2 Device Recall Modular Hip and Knee Replacement System see related information
Date Initiated by Firm November 15, 2007
Date Posting Updated February 26, 2008
Recall Status1 Terminated 3 on September 22, 2008
Recall Number Z-0927-2008
Recall Event ID 45947
510(K)Number K952970  
Product Classification Semi-Constrained Metal/Polymer Cemented Hip Prosthesis - Product Code JDI
Product Stryker Modular Replacement System Curved Cemented Stem;
MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430
Code Information Catalog Number: 6485-3-717;, Lot Codes: LCDCH, TEC029A, TEC057A, TEC089B, TEC089C, TEC089D, TEC089E, TEC089E2, TEC089F, TEC089G, TEC089G1, TEC089H1, TEC089I1, TEC144, TEC145, TE 259, TEC301.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Rita Intorella
201-831-6633
Manufacturer Reason
for Recall
Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
FDA Determined
Cause 2
Process design
Action On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633.
Quantity in Commerce 803 total, all sizes
Distribution Nationwide Distribution
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 = JDI and Original Applicant = HOWMEDICA CORP.
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