Device product
ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
Z-0148-2016
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 72108
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0148-2016
Official wording
Reason: May contain small amounts of ethylene glycol residue
Code information: Serial Number: OUS 0354195
Distribution pattern: Distributed Nationwide and in Germany, Switzerland, and UK.
Derived failure modes
-
Foreign material or chemical contamination
ethylene glycol