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U.S. Department of Health and Human Services

Class 2 Device Recall Metasul Head

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 Class 2 Recall
Metasul Head
see related information
Date Posted October 25, 2013
Recall Status1 Open
Recall Number Z-0071-2014
Recall Event ID 65799
Premarket Notification
510(K) Number
K091973 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - Product Code KWA
Product Metasul® Head. Intended for use either with or without bone cement in total hip arthroplasty.
Code Information Part Number Range:00-8770-040-01/05 & 01.01062.405/408
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.
Quantity in Commerce 194 (8770-040)
Distribution Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
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 = ZIMMER GMBH
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