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    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

    FDA Recall
    Terminated ·Covidien LLC·Product code FSY·April 16, 2015

    RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code LLL·November 25, 2008

    MAS Omni Immune Controls

    FDA Recall
    Terminated ·Microgenics Corporation·Product code JJY·December 2, 2013

    MAS Omni Immune PRO Controls

    FDA Recall
    Terminated ·Microgenics Corporation·Product code JJY·December 2, 2013

    White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GGK·December 19, 2007

    Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.

    FDA Recall
    Terminated ·Covidien, PLC·Product code GEI·February 6, 2009

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Recall
    Open, Classified ·NOA Medical Industries Inc·Product code IKX·November 5, 2024

    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·January 15, 2015

    ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.

    FDA Recall
    Terminated ·Baxter Corporation Englewood·Product code NEP·April 8, 2015

    ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code DHN·December 4, 2008

    Lodox Statscan digital radiographic system.

    FDA Recall
    Terminated ·Lodox Na Llc·May 10, 2004

    Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

    FDA Recall
    Open, Classified ·PYRAMES INC·Product code DXN·February 24, 2025

    DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd, Leeds, United Kingdom.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·March 5, 2010

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T, Zimmer, Winterthur, Switzerland; REF 01.00214.160. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 66/60, code Z, Zimmer, Winterthur, Switzerland; REF 01.00214.166. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWA·July 22, 2008

    ASR TAP SLV ADAP 12/14 +5, DEPUY ASR ACETABULAR CUP SYSTEM, ASR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL). The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    TOTAL ASR ACET IMP SIZE 70, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR ACETABULAR IMPLANT 48, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The DePuy ASR TM Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010

    ASR 300 Size 60, DEPUY ASR 300 ACETABULAR CUP SYSTEM. The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. Prescription Use, Sterile The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·August 23, 2010