Device product
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
Z-0143-2016
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 72108
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-0143-2016
Official wording
Reason: May contain small amounts of ethylene glycol residue
Code information: Serial Numbers (US): 0354902, 0353696 Serial Numbers (OUS): 0349179 0352344 0352431 0352626 0353845 0353883 0353884 0354625 0355002 0355181
Distribution pattern: Distributed Nationwide and in Germany, Switzerland, and UK.
Derived failure modes
-
Foreign material or chemical contamination
ethylene glycol