Device product
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
Z-0991-2017
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 75969
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0991-2017
Official wording
Reason: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Code information: Serial Number: 0384180
Distribution pattern: Distribution to TX only
Derived failure modes
-
Unknown
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).