Device product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Z-1070-2016
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 73246
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1070-2016
Official wording
Reason: Incorrect femoral component distributed
Code information: Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108
Distribution pattern: KY
Derived failure modes
-
Unknown
Incorrect femoral component distributed