ConForMIS iUni Unicondylar Knee Replacement System recall
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
Why was ConForMIS iUni Unicondylar Knee Replacement System 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): 0355239 0355108 0355474 0354538 Serial Numbers (OUS): 0353919 0354845 0354849
- Product
- ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
- Recalling firm
- ConforMIS, Inc.
- Quantity
- 7 units
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Recall date
- October 28, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)