BEUDAMED
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    KWI (TM) G-CO/TWO

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Pediatric Extremity Combo K-Wire System

    FDA UDI
    Wishbone Medical, Inc.·B562KITKWIEXLAR0·

    Pediatric Elbow Combo K-Wire System

    FDA UDI
    Wishbone Medical, Inc.·B562KITKWIELBOW0·

    Pediatric Long Bone Combo K-Wire System

    FDA UDI
    Wishbone Medical, Inc.·B562KITKWILBONE0·

    Pediatric Extremity Combo K-Wire System

    FDA UDI
    Wishbone Medical, Inc.·B562KITKWIEXMED0·

    Pediatric Extremity Combo K-Wire System-SMALL

    FDA UDI
    Wishbone Medical, Inc.·B562KITKWIEXSML0·

    PROSTHESIS, HIP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

    V40 COCR LFIT HEAD 36MM/0

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK STRYKR ORTHOPAEDICS·Product code KWY·February 5, 2010

    PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWI·April 7, 2016

    UNK - MONO/POLYAXIAL SCREWS : 6.5MMX45MM: VIPER II

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·September 10, 2021

    ARCOM RNGLC TRI-POLAR LNR SZ26 - TRI-POLAR SYSTEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·October 2, 2014

    MAXI SKY 600

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·February 16, 2017

    Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 500104428 BIPOLAR LINER 44/45/46MM 500104422 BIPOLAR LINER 44MM OD X 2 500104426 BIPOLAR LINER 44MM OD X 2 500104728 BIPOLAR LINER 47/48/49MM 500104722 BIPOLAR LINER 47MM OD X 2 500104726 BIPOLAR LINER 47MM OD X 2 500104732 BIPOLAR LINER 47MM OD X 3 500105028 BIPOLAR LINER 50/51/52MM 500105022 BIPOLAR LINER 50MM OD X 2 500105026 BIPOLAR LINER 50MM OD X 2 500105328 BIPOLAR LINER 53/54/55MM 500105322 BIPOLAR LINER 53MM OD X 2 500105326 BIPOLAR LINER 53MM OD X 2 500105728 BIPOLAR LINER 57/58MM OD 500105722 BIPOLAR LINER 57MM OD X 2 500106028 BIPOLAR LINER 60/62MM OD 500106828 BIPOLAR LINER 68/70MM OD 500106832 BIPOLAR LINER 68MM OD X 3 500107228 BIPOLAR LINER 72MM OD X 2 500103800 BIPOLAR SHELL 38MM OD 500103900 BIPOLAR SHELL 39MM OD 500104000 BIPOLAR SHELL 40MM OD 500104100 BIPOLAR SHELL 41MM OD 500104200 BIPOLAR SHELL 42MM OD 500104300 BIPOLAR SHELL 43MM OD 500104400 BIPOLAR SHELL 44MM OD 500104500 BIPOLAR SHELL 45MM OD 500104600 BIPOLAR SHELL 46MM OD 500104700 BIPOLAR SHELL 47MM OD 500104800 BIPOLAR SHELL 48MM OD 500104900 BIPOLAR SHELL 49MM OD 500105000 BIPOLAR SHELL 50MM OD 500105100 BIPOLAR SHELL 51MM OD 500105200 BIPOLAR SHELL 52MM OD 500105300 BIPOLAR SHELL 53MM OD 500105400 BIPOLAR SHELL 54MM OD 500105500 BIPOLAR SHELL 55MM OD 500105700 BIPOLAR SHELL 57MM OD 500105800 BIPOLAR SHELL 58MM OD 500106000 BIPOLAR SHELL 60MM OD 500106200 BIPOLAR SHELL 62MM OD 500107000 BIPOLAR SHELL 70MM OD Product Usage: For use in total or hemi hip arthroplasty

    FDA Recall
    Terminated ·Product code KWY·January 11, 2016

    Prosthesis, Elbow, Hemi-, Radial, Polymer

    FDA classification
    FDA Class 2 ·Prosthesis, Elbow, Hemi-, Radial, Polymer

    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

    FDA classification
    FDA Class 2 ·Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

    UNKNOWN SUMMIT SZ 5 HI TAPERED STEM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·November 17, 2016

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWY·December 21, 2016

    UNKNOWN DEPUY SZ. 28 +12 FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·November 29, 2016

    UNKNOWN DEPUY SUMMIT STEM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·November 15, 2016

    TAPER SLEEVE ADAPTER 12/14 +2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWY·October 13, 2016