Zimmer, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0080-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 30, 2013

Date Posted: November 6, 2013

Recall Number: Z-0080-2014

Event ID: 65799

Reason for Recall:

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

Status: Terminated

Product Quantity: 3475

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.

Voluntary or Mandated:

Voluntary: Firm initiated