FDAClass IINovember 6, 2013

Natural-Knee¿ II Femoral Component recall

Natural-Knee¿ II Femoral Component

Why was Natural-Knee¿ II Femoral Component 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:6212, 6307-00-006/051

Product
Natural-Knee¿ II Femoral Component
Recalling firm
Zimmer, Inc.
Quantity
13483
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)
Open FDA enforcement record Latest recalls