Device product
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
Z-0142-2016
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 72108
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0142-2016
Official wording
Reason: May contain small amounts of ethylene glycol residue
Code information: Serial Numbers: 0351869
Distribution pattern: Distributed Nationwide and in Germany, Switzerland, and UK.
Derived failure modes
-
Foreign material or chemical contamination
ethylene glycol