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U.S. Department of Health and Human Services

Class 2 Device Recall Versys Hip System femoral stem

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  Class 2 Device Recall Versys Hip System femoral stem see related information
Date Initiated by Firm January 07, 2003
Date Posting Updated January 28, 2003
Recall Status1 Terminated 3 on February 09, 2004
Recall Number Z-0472-03
Recall Event ID 25375
510(K)Number K922071  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 11, standard body. Cat. No. 7841-11-10.
Code Information All lots.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E. Main St.
Warsaw IN 46580
For Additional Information Contact
574-267-6131
Manufacturer Reason
for Recall
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
FDA Determined
Cause 2
Other
Action Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
Distribution United States, Australia 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 = LPH and Original Applicant = ZIMMER, INC.
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