BEUDAMED
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    Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·July 2, 2014

    ACCELL EVO3C

    FDA Adverse Event
    Injury ·SEASPINE INC.·Product code MBP·August 7, 2020

    ACCELL EVO3C

    FDA Adverse Event
    Injury ·SEASPINE INC.·Product code MBP·August 7, 2020

    Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code MBP·May 19, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 12, 2013

    SMARTSITE ACCESS PIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SAFSITE NEEDLELESS IV ACCESS PIN

    FDA Adverse Event
    Malfunction ·BURRON MEDICAL, INC.·Product code FPA·April 12, 1994

    GETTIG UNIVERSAL VIAL ACCESS PIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD¿ VIAL ACCESS DEVICE (NEEDLE FREE)

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 4, 2022

    SAFESITE ACCESS PIN

    FDA Adverse Event
    Malfunction ·BURRON MEDICAL, INC.·Product code FOZ·May 4, 1994

    ACCESS PIN

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code LHI·December 13, 1993

    SAFSITE NEEDLEFREE SYSTEM ACCESS PIN

    FDA Adverse Event
    Malfunction ·BURRON MEDICAL, INC.·Product code FPA·June 8, 1994

    MONOJECT BLUNTIP

    FDA Adverse Event
    Malfunction ·KENDALL·Product code FMI·June 18, 2014

    ACCESS PIN

    FDA Adverse Event
    Other ·BURRON MEDICAL, INC.·Product code FPA·December 29, 1993

    B. BRAUN - SAFSITE

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FMI·May 21, 1998

    SMART SITE

    FDA Adverse Event
    Malfunction ·*·Product code FPA·February 27, 2004

    B. BRAUN

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FPA·August 1, 1998

    BD PYXIS¿ MEDBANK TOWER

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·April 2, 2026

    ACCESS PIN

    FDA Adverse Event
    Malfunction ·BURRON MEDICAL INC.·March 8, 1994

    MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital