BEUDAMED
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    Exactech® Vantage® Total Ankle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Plateau-V Spacer System

    FDA UDI
    Life Spine, Inc.·00190837029128·PLATEAU-V Interbody, Straight, Bulleted, 12mm x...

    ENDO GIA RELOAD

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CLEWICU System (ClewICUServer and ClewICUnitor)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDEAVOR RESOLUTE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·November 6, 2014

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·August 17, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·Product code HEB·July 17, 2013

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024