BEUDAMED
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    LACTOSORB PANELS AND FASTENERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984390·anteriors; shade B4; mould 90

    P.F.C.

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295252573·P.F.C. TIBIAL INSERT FIXED BEARING CURVED 3N 8m...

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707035563·.019 X .025 Lower Elastinol™ Natural Form Archw...

    INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTI-HUMAN LEU-2A (CD8) PE

    FDA 510(k)
    FDA Class 2 ·Hematology

    VANGUARD COMPLETE KNEE SYSTEM - BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 23, 2017

    VANGUARD PATELLA COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 23, 2017

    SERIES A PAT THN 28 3 PEG

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 6, 2017

    BIOMET COCR FINNED TIB TRAY 67 MM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 6, 2017

    BIOMET TIBIAL TRAYS

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 23, 2017

    E1 VNGD AS TIB BRG 11X67

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 6, 2017

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·February 10, 2011

    TRIDENT X3 ECCENTRIC 0° 32MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·August 6, 2014

    Vanguard XP Tibial Tray 71 mm Item # 195249

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019