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    KM-4(TM) METAL-BACKED ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    FTRD System Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INOMAX DS (DELIVERY SYSTEM), MODEL 10003

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·June 12, 2014

    GENTLEPOWER LUX CONRA ANGLE 25LPA

    FDA Adverse Event
    Injury ·KAVO DENTAL GMBH·Product code EFB·October 7, 2010

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 12, 2012

    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