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    K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique.

    FDA Recall
    Terminated ·Product code OLO·December 2, 2016

    K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·October 16, 2019

    YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Catalog Numbers 7601-03512, 7601-03514, 7601-03532, 7601-03534, 7601-03538L, 7601-03540L, 7601-04016L, 7601-04018L, 7601-04020L, 7601-04022L, 7601-04024L, 7601-04026L, 7601-04028L, 7601-04030, 7601-05022, 7601-05028, 7601-05030

    FDA Recall
    Terminated ·Product code NKG·July 24, 2018

    Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    FDA Recall
    Terminated ·Product code KNW·April 18, 2019

    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    FDA Recall
    Terminated ·Product code KNW·April 18, 2019

    Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·June 5, 2019

    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·June 5, 2019

    Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code KXT·July 20, 2007

    In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).

    FDA Recall
    Terminated ·Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila·Product code MGU·March 23, 2005

    Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JJE·September 8, 2006

    AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code JIS·March 6, 2008

    Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIS·September 7, 2006

    Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIT·September 7, 2006

    Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIT·September 7, 2006

    Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCD·October 26, 2007

    ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.

    FDA Recall
    Terminated ·Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LOL·December 30, 2009

    AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code KXT·May 22, 2008

    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·May 27, 2020