NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Reported: November 6, 2013 Initiated: August 30, 2013 #Z-0080-2014
Product Description
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
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
- 3475
- 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? ▼
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States). Recalled by Zimmer, Inc.. Units affected: 3475.
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-0080-2014.
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