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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 Recall
Versys Hip System femoral stem
see related information
Date Posted January 28, 2003
Recall Status1 Open
Recall Number Z-0472-03
Recall Event ID 25375
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, Indiana 46580
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.
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.

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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