BEUDAMED
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    STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANIT-ENA ANTIBODY TEST [SS-B (LA)]

    FDA 510(k)
    FDA Class 2 ·Immunology

    PCA ACETABULAR INSERT II

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 2, 2014

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 16, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 11, 2010

    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