iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL ...



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.
Components:
Units Affected:    2
Recall Date:    Feb 3, 2020
Mfg:
Conformis, Inc.
Mfg Country:
United States
Recall ID:    85108
Product ID:    180103
Enforcement Date:    Apr 8, 2020
Termination Date:    Dec 2, 2020
Last Published:    Dec 2, 2020

__________

Emert Number:    Z-1628-2020
Emert Status:    Terminated