BEUDAMED
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    ITT INTERGRATED TABLE AND TUBESTAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    Encore Neutral

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS

    FDA 510(k)
    FDA Class 2 ·Radiology

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014

    CAPSURE EPI

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·October 9, 2010

    SEE H-10

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·December 10, 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