60 results
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11ms
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Sources: EU EUDAMED, US FDA
IgE Calibrator Series
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code DGC·September 7, 2016
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DGC·March 5, 2018
Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code DGC·January 5, 2009
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·April 17, 2020
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·August 25, 2017
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·August 25, 2017
Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Thin Patella size 25mm, one peg - 184720 Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems. Knee joint patellofemorotibial, cemented, polymer /metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·July 24, 2007
Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·July 24, 2007
Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthopedics, Warsaw, IN 46582 Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. For use with Vanguard, Maxim, Ascent & ACG knee system. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·October 4, 2011
Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
FDA Recall
Terminated
·DPC Cirrus·Product code DHA·October 29, 2004
Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
FDA Recall
Terminated
·DPC Cirrus·Product code JJE·June 13, 2003