FDA-Device2013-11-06Class II
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
Zimmer, Inc.
Hazard
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Sold states
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.
Affected count
194 (8770-040)
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2014Don't want to check this manually?
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