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.
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
US Nationwide distribution in the states of LA, NY, TN.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1628-2020