Device product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Z-0899-2022
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 89903
- Status
- Completed
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0899-2022
Official wording
Reason: Incorrect tibial base plate implant packaged in kit
Code information: Serial Number: 0496242 UDI: M572TPS3011113011
Distribution pattern: MS
Derived failure modes
-
Unknown
Incorrect tibial base plate implant packaged in kit