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U.S. Department of Health and Human Services

Class 2 Device Recall Hip Prostheses

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  Class 2 Device Recall Hip Prostheses see related information
Date Initiated by Firm December 26, 2002
Date Posted February 25, 2003
Recall Status1 Terminated 3 on April 22, 2003
Recall Number Z-0569-03
Recall Event ID 25395
Product Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
Code Information Catalog # 115-1015, Lot # W016134, W017080. Catalog # 115-1319, Lot # W016434.
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 Business Park Drive
Draper UT 84020
Manufacturer Reason
for Recall		 Cleaning agent residue from packaging material was adhering to implantable hip stems.
FDA Determined
Cause 2		 Other
Action Consignees were notified on 12/26/2002 via telephone and e-mail.
Quantity in Commerce 14
Distribution TX and Japan
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.
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