Conformis Itotal CR Knee Replacement System- Itotal CR recall
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT…
Why was Conformis Itotal CR Knee Replacement System- Itotal CR 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): 0354697, 0353789, 0354533
- Product
- ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT…
- Recalling firm
- ConforMIS, Inc.
- Quantity
- 3 units
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Recall date
- October 28, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)