NexGen CR-Flex Mobile Bearing Tibial Component 9 recall
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Why was NexGen CR-Flex Mobile Bearing Tibial Component 9 recalled?
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number Range:005930-010/080-01/02
- Product
- NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
- Recalling firm
- Zimmer, Inc.
- Quantity
- 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.
- Recall date
- November 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)