BEUDAMED
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    AXIOM TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSMEX POCH-100I

    FDA 510(k)
    FDA Class 2 ·Hematology

    ULTRASOUND SCANNER FLEX FOCUS 1202

    FDA 510(k)
    FDA Class 2 ·Radiology

    CERVIOS TRIAL-IMPL CURVED SIZ 6 GOLD

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWT·January 29, 2013

    SUREFIRE SCORPION NEEDLE

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRX·December 20, 2010

    GRAFTON DBM

    FDA Adverse Event
    Injury ·OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)·Product code MBP·July 14, 2014

    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 REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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