Device product
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
Z-0144-2016
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 72108
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0144-2016
Official wording
Reason: May contain small amounts of ethylene glycol residue
Code information: Serial Numbers (US): 0354697, 0353789, 0354533
Distribution pattern: Distributed Nationwide and in Germany, Switzerland, and UK.
Derived failure modes
-
Foreign material or chemical contamination
ethylene glycol