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Recall Observatory FDA recall evidence

Device product

NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)

Z-0080-2014

August 30, 2013

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 65799
Status
Terminated
Classification
Class II
Quantity
3475
Official record key
device-enforcement:Z-0080-2014

Official wording

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

Code information: Part Number Range:005930-010/080-01/02

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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