BEUDAMED
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    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·March 2, 2016

    CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses

    FDA Enforcement
    Class II ·Terminated·CAREstream Medical LLC·August 29, 2018

    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

    FDA Enforcement
    Class II ·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017

    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Precision PCx Test Strips Part Number: 98757-12

    FDA Recall
    Terminated ·Abbott Laboratories, Inc.·Product code CGA·November 8, 2002

    This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NJT·December 30, 2015

    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 Enforcement
    Class II ·Terminated·Shimadzu Medical Systems·November 14, 2012

    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·November 6, 2013

    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

    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

    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