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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 06, 2003
Date Posted January 23, 2003
Recall Status1 Terminated 3 on December 04, 2003
Recall Number Z-0459-03
Recall Event ID 25257
510(K)Number k012793  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
Product Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on Co-Cr 12/14 tapers . Cat. No. 6418-26-02.
Code Information All lots.
Recalling Firm/
Zimmer Inc.
345 E. Main St.
Warsaw IN 46580
For Additional Information Contact
Manufacturer Reason
for Recall
Compression test results are not in accordance with device approval submission
FDA Determined
Cause 2
Action Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
Distribution United States.
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.