FDA-Device2013-11-06Class II
Sidus" Head (Not distributed in the United States)
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
0 in USA
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
Sidus" Head (Not distributed in the United States)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2014Don't want to check this manually?
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