ClearanceBrief
Recall Z-2849-2020 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Conformis, Inc.

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

DateJul 20, 2020
StatusTerminated
ReasonOuter box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Root causePackaging process control
ActionConformis notification to field sales representative on July 20,2020 to remove product from use.
Quantity1 kit
DistributionNV
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Conformis, Inc., May 16, 2018