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    3mensio Workstation (Vascular Fenestrated) software

    FDA Recall
    Open, Classified ·PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands·Product code LLZ·July 14, 2025

    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code HST·February 28, 2013

    BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons.

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007

    BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·December 28, 2005

    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code HST·January 3, 2017

    Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code HST·November 23, 2016

    Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 16, 2011

    BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.

    FDA Recall
    Terminated ·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007

    ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018

    ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011

    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011

    ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018

    ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.

    FDA Recall
    Terminated ·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018

    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

    FDA Recall
    Terminated ·Southern Implants, (Pty.) Ltd. One Albert Road Irene, Gauteng South Africa·Product code NHA·March 8, 2018

    McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

    FDA Recall
    Open, Classified ·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024

    MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

    FDA Recall
    Open, Classified ·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024

    Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: pressure ulcers leg ulcers cavity wounds lacerations post-operative surgical wounds

    FDA Recall
    Open, Classified ·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024

    Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

    FDA Recall
    Terminated ·The OR Group, Inc. A Subsidiary of Hill-Rom Inc. One Post Office Square·Product code FWZ·June 2, 2003