Recall Z-0991-2017 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

ConforMIS, Inc.

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

Date	Jan 10, 2017 (initiated Oct 31, 2016)
Status	Terminated
Reason	iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Root cause	Software Design Change
Action	ConForMIS intiated the recall by telephone on October 31, 2016, to the Sales Rep to request return of the kit. For questions regarding this recall call 781-345-9001.
Quantity	1 unit
Distribution	Distribution to TX only
FDA record	Open on fda.gov

510(k) clearances named in this recall

K161668

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
Conformis, Inc., Jul 15, 2016