FDAClass IIMarch 16, 2016

Conformis iTotal Cruciate Retaining recall

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Why was Conformis iTotal Cruciate Retaining recalled?

Incorrect femoral component distributed

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:0363410 UDI - M572TCR1111111021/$$316073103634108

Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Recalling firm
ConforMIS, Inc.
Quantity
1 unit
Distribution
KY
Recall date
March 16, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls