BEUDAMED
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    2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code NDL·October 2, 2019

    Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGL·November 2, 2007

    S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGL·December 16, 2011

    Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGL·August 11, 2008

    Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGL·November 2, 2007

    Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGL·March 26, 2009

    i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGL·March 17, 2010

    Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGL·November 2, 2007

    Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGL·October 29, 2014

    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·April 1, 2015

    Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico, Inc. Road·Product code HNN·March 3, 2004

    Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HWC·February 16, 2015

    Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·August 12, 2015

    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013

    Stylus Brand Angled Knife 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm 52-3231, Slit Knife, double bevel, angled, full handle, 3.2mm

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico, Inc. Road·Product code HNN·March 3, 2004

    Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled. 54-1031, Sharptome Crescent Knife, double bevel, angled, full handled

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico, Inc. Road·Product code HNN·March 3, 2004

    Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico, Inc. Road·Product code HNN·March 3, 2004

    Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full handle, 3.0mm 52-3212, Slit Knife, parallel sides, bevel up, angled, full handle, 3.2mm

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico, Inc. Road·Product code HNN·March 3, 2004

    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·September 14, 2016

    Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 12, 2014