BEUDAMED
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    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·December 10, 2013

    STRYKER PAINPUMP2

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EARPROBE

    FDA 510(k)
    FDA Class 2 ·Neurology

    GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 26, 2024

    CORTSCR Ø4.5 L36 SST

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KTT·May 24, 2013

    JAGTOME? RX 44

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·September 30, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    NOVOSYN QUICK UNDY 2/0(3)70CM DSMP24MDDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·April 23, 2021

    NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2021

    NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021

    NOVOSYN QUICK UNDY 3/0(2)70CM DS19(M)DDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021

    NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021

    NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 29, 2021

    NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021

    NOVOSYN QUICK UNDY 4/0(1,5)45CM DS19MDDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 3, 2021

    NOVOSYN QUICK UNDY 3/0(2)70CM HR17(M)DDP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·November 17, 2020