FDA-Device2013-11-06Class II

Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.

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
72806
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2014

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