BEUDAMED
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    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HRS·October 10, 2019

    Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

    FDA Recall
    Open, Classified ·Philips Ultrasound, LLC·Product code IYN·October 31, 2025

    R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZW·October 28, 2011

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Recall
    Open, Classified ·MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China·Product code RHP·October 26, 2021

    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.

    FDA Recall
    Terminated ·Orthofix, Inc·Product code FZX·May 11, 2015

    Endoscopic Introducer/Extractor

    FDA Recall
    Terminated ·Cook Inc.·Product code FZX·April 25, 2017

    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code FZX·August 21, 2019

    Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code FZX·August 6, 2009

    Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876; 9359540; 9494322; 9590744; 9661608; 9359339; 9501935; 9590747; 9371095; 9505477; 9604306 These devices are specific to the Trochanteric Fixation Nail Advanced (TFNA) system. The TFNA Proximal Femoral Nailing System is for the treatment of intramedullary fixation of proximal femoral fractures

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code FZX·June 7, 2016

    2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code FZX·August 21, 2019

    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    FDA Recall
    Completed ·Hologic, Inc·Product code FZX·October 10, 2022

    ITST THREADED GUIDE PIN

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code FZX·November 5, 2013

    REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex AP sizing guide.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code FZX·February 10, 2011

    Zimmer Guide Wires for orthopedic procedures.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code FZX·August 27, 2015

    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code FZX·February 16, 2016

    Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. These instruments are used in support of the surgery.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code FZX·August 9, 2016