BEUDAMED
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    SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OREAI-Q-TU TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR

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

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 10, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 23, 2015

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021