FDA-Device2013-11-06Class II
CoCr Head (Not distributed in the United States) Used in total hip replacement.
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
604064 total
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
CoCr Head (Not distributed in the United States) Used in total hip replacement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2014Don't want to check this manually?
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