PlainRecalls

ConforMIS, Inc.

21 recalls on record · Latest: Apr 23, 2025

FDA Devices Moderate Apr 23, 2025

restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

FDA Devices Moderate Apr 24, 2024

Identity Imprint PS Tibial Tray Size 4: Lot 540287

FDA Devices Moderate Apr 20, 2022

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

FDA Devices Moderate Dec 2, 2020

iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as t…

FDA Devices Moderate Sep 2, 2020

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

FDA Devices Moderate Dec 18, 2019

iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a …

FDA Devices Moderate Oct 16, 2019

iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right

FDA Devices Moderate Apr 17, 2019

iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: …

FDA Devices Moderate Apr 10, 2019

iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

FDA Devices Moderate Jan 23, 2019

iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

FDA Devices Moderate Dec 7, 2016

ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacem…

FDA Devices Moderate Mar 16, 2016

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

FDA Devices Moderate Oct 28, 2015

ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M57…

FDA Devices Moderate Oct 28, 2015

ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT06000…

FDA Devices Moderate Oct 28, 2015

ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722I…

FDA Devices Moderate Oct 28, 2015

ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M57…

FDA Devices Moderate Oct 28, 2015

ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230

FDA Devices Moderate Oct 28, 2015

ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) …

FDA Devices Moderate Oct 28, 2015

ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog N…

FDA Devices Moderate Dec 17, 2014

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee j…

FDA Devices Moderate Aug 29, 2012

Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right K…