BEUDAMED
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    Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Biomet Orthopedics, Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

    BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; b) Manufactured for Sunrise Medical, Longmont, CO 80503: Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FRW·December 19, 2007

    DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Manufactured by Del Medical Imaging Corporation, Franklin Park, IL 60131 U.S.A.

    FDA Recall
    Terminated ·Del Medical Systems Group·Product code IYB·February 13, 2004

    Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021

    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

    FDA Enforcement
    Class II ·Terminated·Ortho Development Corporation·May 21, 2014

    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

    FDA Recall
    Terminated ·Ortho Development Corporation·Product code JWH·April 1, 2014

    Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021

    Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.

    FDA Recall
    Terminated ·Ortho Development Corporation·Product code JWH·May 29, 2009

    Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTN·February 4, 2021

    Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTN·February 4, 2021

    Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792 The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems: a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes; b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes; c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code EPT·April 12, 2005

    Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021

    Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021

    Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021

    Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Enforcement
    Class I ·Terminated·Medtronic Perfusion Systems·March 24, 2021