PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 6, 2013 Initiated: August 30, 2013 #Z-0068-2014

Product Description

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

Reason for Recall

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
72806
Distribution
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.. Recalled by Zimmer, Inc.. Units affected: 72806.
Why was this product recalled?
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0068-2014.