Device product
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR 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-1628-2020
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 85108
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1628-2020
Official wording
Reason: A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Code information: 0460018 0460118
Distribution pattern: US Nationwide distribution in the states of LA, NY, TN.
Derived failure modes
-
Unknown
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.