FDAClass IIOctober 28, 2015

ConForMIS iUNI Unicondylar Knee Replacement System iUNI recall

ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)

Why was ConForMIS iUNI Unicondylar Knee Replacement System iUNI 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): 0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233

Product
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
Recalling firm
ConforMIS, Inc.
Quantity
6 units
Distribution
Distributed Nationwide and in Germany, Switzerland, and UK.
Recall date
October 28, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls