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Zimmer, Inc. recalls NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Recalled November 6, 2013 · FDA recall Z-0080-2014 · Zimmer
Hazard
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. · FDA Class II
Units
3475
Sold at
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.
Description
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Product
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →