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Zimmer, Inc. recalls Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
Recalled November 6, 2013 · FDA recall Z-0071-2014 · 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
194 (8770-040)
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
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →