56 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.
FDA Enforcement
Class II
·Terminated·Draeger Medical, Inc.·April 16, 2014
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code BZO·March 25, 2014
Naera Hospital Bassinet, Model No. 4402
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code NZG·October 10, 2018
REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·March 20, 2013
Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 2.5mm CAT 04-33-0011; SIZE 2 x 2.5mm CAT 04-33-0012; SIZE 3 x 2.5mm CAT 04-33-0013; SIZE 4 x 2.5mm CAT 04-33-0014; SIZE 5 x 2.5mm CAT 04-33-0015; SIZE 6 x 2.5mm CAT 04-33-0016. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 5mm CAT 04-33-0021; SIZE 2 x 5mm CAT 04-33-0022; SIZE 3 x 5mm CAT 04-33-0023; SIZE 4 x 5mm CAT 04-33-0024; SIZE 5 x 5mm CAT 04-33-0025; SIZE 6 x 5mm CAT 04-33-0026. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X5 CAT 04-63-2123; SIZE 3-4X5 CAT 04-63-2124; SIZE 3-5X5 CAT 04-63-2125; SIZE 3-6X5 CAT 04-63-2126. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X0 CAT 04-63-2103; SIZE 3-4X0 CAT 04-632104; SIZE 3-5X0 CAT 04-63-2105; SIZE 3-6X0 CAT 04-63-2106. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011
Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
"***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
Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
"***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
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***CAT.NO.***SIZE***" SIZE 3-3X7.5 CAT 04-63-2133; SIZE 3-4X7.5 CAT 04-63-2134; SIZE 3-5X7.5 CAT 04-63-2135; SIZE 3-6X7.5 CAT 04-63-2136. Tricompartmental Knee Replacement
FDA Recall
Terminated
·Endotec, Inc.·Product code NRA·September 21, 2011