FDAClass IIDecember 17, 2014

Conformis iTotal CR G2 Knee Replacement System recall

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint…

Why was Conformis iTotal CR G2 Knee Replacement System recalled?

Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

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?

Serial Number: 0340552

Product
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint…
Recalling firm
ConforMIS, Inc.
Quantity
1 unit
Distribution
Distributed to IN.
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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