ClearanceBrief
Recall Z-1070-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

ConforMIS, Inc.

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

DateJan 28, 2016
StatusTerminated
ReasonIncorrect femoral component distributed
Root causePackaging process control
ActionConformis notiifed the surgeon via the sales rep on 1/28/16 of the error and the correct femoral component was processed. The surgeon received it on February 1, 2016.
Quantity1 unit
DistributionKY
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K142161ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
Conformis, Inc., Nov 14, 2014