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Zimmer, Inc. recalls CoCr Head (Not distributed in the United States) Used in total hip replacement.
Recalled November 6, 2013 · FDA recall Z-0072-2014 · 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
604064 total
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
CoCr Head (Not distributed in the United States) Used in total hip replacement.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →