BEUDAMED
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    HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707035846·.017 X .025 Upper Stainless Steel Resilient Int...

    BIOPRO TRINITY ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CK-MB/LD-1 CONTROL SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 8, 2013

    VARIAX DR AIMING BLOCK JOYSTICK

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG (MDR)·Product code HRS·August 8, 2014

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·February 16, 2011

    SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·November 22, 2023

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 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