Device product
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
Z-0141-2016
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 72108
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 units
- Official record key
device-enforcement:Z-0141-2016
Official wording
Reason: May contain small amounts of ethylene glycol residue
Code information: Serial Numbers (US): 0355146 0354541 0355265 0354782 0355485 0355303 0352821 0354413 0353756 0351007 0354577 0354250 0352676 0354571 0353838 0353285 0347734 0354520 0354841 0354148 0353307 0355478 0354830 0353427 0353729 0353683 0353887 0351415 0354255 0354219 0355807 0353995 0352944 0353305 0352331 Serial Numbers (OUS): 0347979 0349420 0351218 0351279 0351682 0351688 0351754 0351856 0352523 0352868 0352918 0353077 0353416 0353745 0353805 0353933 0354141 0354189 0354190 0354267 0354325 0354421 0354427 0354561 0354600 0354646 0354678 0354810 0354850 0355339 0355382 0355385
Distribution pattern: Distributed Nationwide and in Germany, Switzerland, and UK.
Derived failure modes
-
Foreign material or chemical contamination
ethylene glycol