BEUDAMED
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    Eius Unicompartmental Knee System Stryker Howmedica Osteonics Corp. Howmedica International S. de R.L., Raheen Business Park, Limerick, Ireland. Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment, preservation of ligaments and patellofemoral articulation, reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code NPJ·August 17, 2011

    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code NPJ·January 9, 2014

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code NPJ·January 15, 2016

    The Triathlon Posteriorly Stabilized Femoral Component.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code NPJ·October 27, 2004

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

    FDA Recall
    Terminated ·ConforMIS, Inc.·Product code NPJ·August 31, 2015

    ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)

    FDA Recall
    Terminated ·ConforMIS, Inc.·Product code NPJ·August 31, 2015

    Restoris MCK Onlay Insert Extractor.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code NPJ·January 19, 2018

    ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)

    FDA Recall
    Terminated ·ConforMIS, Inc.·Product code NPJ·August 31, 2015

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022

    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

    FDA Recall
    Terminated ·BioPro, Inc.·Product code KWD·February 1, 2022