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U.S. Department of Health and Human Services

Class 3 Device Recall Zimmer Metasul Head

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 Class 3 Recall
Zimmer Metasul Head
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on January 05, 2009
Recall Number Z-2299-2008
Recall Event ID 48715
Premarket Notification
510(K) Number
K033634 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - Product Code KWA
Product Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.
Code Information Lot 2299218.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The wrong part may be in the package. Package may contain a 28 mm head.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Zimmer notified consignees via recall letter dated 6/20/08 to return the product.
Quantity in Commerce 4
Distribution Florida, Pennsylvania, Texas and Virginia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = CENTERPULSE ORTHOPEDICS, INC.
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