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Sources: EU EUDAMED, US FDA
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ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code JDI·April 12, 2007
ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code JDI·April 12, 2007
Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty
FDA Recall
Terminated
·Product code LPH·January 11, 2016
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
FDA Recall
Terminated
·Orthofix, Inc.·Product code KWP·November 26, 2013
Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
FDA Recall
Terminated
·Blackstone Medical, Inc.·Product code MNI·May 21, 2009
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1012 Modular Tibial Bearing 2 X 2.5 04-33-1013 Modular Tibial Bearing 3 X 2.5 04-33-1014 Modular Tibial Bearing 4 X 2.5 04-33-1015 Modular Tibial Bearing 5 X 2.5 04-33-1016 Modular Tibial Bearing 6 X 2.5. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1022 Modular Tibial Bearing 2 x 5 04-33-1023 Modular Tibial Bearing 3 X 5 04-33-1024 Modular Tibial Bearing 4 X 5 04-33-1025 Modular Tibial Bearing 5 X 5 04-33-1026 Modular Tibial Bearing 6 X 5. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1032 Modular Tibial Bearing 2 X 7.5 04-33-1033 Modular Tibial Bearing 3 X 7.5 04-33-1034 Modular Tibial Bearing 4 X 7.5 04-33-1035 Modular Tibial Bearing 5 X 7.5 04-33-1036 Modular Tibial Bearing 6 X 7.5. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 18, 2012
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 18, 2012
Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 18, 2012
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 18, 2012
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 18, 2012
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 18, 2012
Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 03022109001 03023109973 03739040001 03739040692 05023572001 05023599001 cobas e 601 module 04745922001 04745922692 05036348001 05036348692 05860652001 cobas e 602 module 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code JJE·June 29, 2017
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" Cat #: 04-33-1002 Modular Tibial Bearing 2 X 0 Cat #: 04-33-1003 Modular Tibial Bearing 3 X 0 Cat #: 04-33-1004 Modular Tibial Bearing 4 X 0 Cat #: 04-33-1005 Modular Tibial Bearing 5 X 0 Cat #: 04-33-1006 Modular Tibial Bearing 6 X 0. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code KWY·August 2, 2007
Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code KWY·August 2, 2007
Foundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code KWY·August 2, 2007
Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
FDA Recall
Terminated
·Product code KWY·August 2, 2007