FDAClass IIOctober 28, 2015

ConForMIS iDuo Knee Bicompartmental Knee Replacement recall

ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)

Why was ConForMIS iDuo Knee Bicompartmental Knee Replacement recalled?

May contain small amounts of ethylene glycol residue

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 Numbers (US): 0354902, 0353696 Serial Numbers (OUS): 0349179 0352344 0352431 0352626 0353845 0353883 0353884 0354625 0355002 0355181

Product
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
Recalling firm
ConforMIS, Inc.
Quantity
12 units
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Recall date
October 28, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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