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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Recall Number Z-0080-2014
Classification Class II
Code Info Part Number Range:005930-010/080-01/02
Product Distributed Qty 3475
Reason For Recall The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Event Detail

Event Id 65799
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.