FDA-Device2013-11-06Class II
Gender Solutions" Patello-Femoral Component
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
5103
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
Gender Solutions" Patello-Femoral Component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2014Don't want to check this manually?
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