554 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·February 25, 2015
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·February 25, 2015
Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. ''
FDA Recall
Terminated
·Exactech, Inc.·Product code JWH·December 19, 2005
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWA·January 9, 2015
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
FDA Recall
Terminated
·Biomet, Inc.·Product code LPH·January 9, 2015
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·August 1, 2012
Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
FDA Recall
Terminated
·Exactech, Inc.·Product code JWH·August 31, 2006
The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
FDA Recall
Terminated
·Exactech, Inc.·Product code JWH·June 2, 2005
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
FDA Enforcement
Class II
·Terminated·Insulet Corporation·March 17, 2021
IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics·October 29, 2014
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.
FDA Enforcement
Class II
·Terminated·Bard Medical Division·August 1, 2018
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·August 29, 2006
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·August 29, 2006
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.
FDA Recall
Terminated
·Exactech, Inc.·Product code NJL·September 23, 2011
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·August 29, 2006
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·August 1, 2012
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015
GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BSZ·August 30, 2010
GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BSZ·August 30, 2010
GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BSZ·August 30, 2010