BEUDAMED
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    DUKAL CORPORATION

    FDA Adverse Event
    Injury ·DUKAL CORPORATION·Product code KGX·January 30, 2010

    DUKAL CORPORATION

    FDA Adverse Event
    Injury ·DUKAL CORPORATION·Product code FQM·February 7, 2010

    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    FDA Recall
    Terminated ·Dukal Corp.·Product code FPY·June 1, 2017

    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    FDA Enforcement
    Class II ·Terminated·Dukal Corp.·December 20, 2017

    NURSE CALL SYSTEM

    FDA Adverse Event
    Other ·DUKANE CORP·Product code ILQ·June 29, 2001

    OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEM CORP.·Product code LQC·February 15, 2016

    Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·March 29, 2004

    Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured by Stryker Spine SAS, Cestas, France; Distributed by Howmedica Osteonics Corp, Mahwah, NJ 07430 Single use device sterilized prior to use. For anterior/anterolateral and posterior noncervical pedicle and non-pedicle fixation for the following: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, psudoartrosis, and failed previous fusion.

    FDA Recall
    Terminated ·Stryker Spine·Product code NKB·April 12, 2007

    Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica osteonics 22.2 mm and 28 mm diameter femoral heads.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·June 3, 2011