BEUDAMED
    34 results · 62ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 26, 2019

    *

    FDA Adverse Event
    Malfunction ·TEDAN SURGICAL INNOVATIONS, LLC·Product code LXH·October 5, 2007

    PHANTOM

    FDA Adverse Event
    Malfunction ·TEDAN SURGICAL INNOVATIONS, LLC·Product code GAD·June 6, 2013

    PHANTOM XL INSULATED DILATORS

    FDA Adverse Event
    Malfunction ·TEDAN SURGICAL INNOVATION LLC·Product code PDQ·August 15, 2019

    Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LXH·April 1, 2019

    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·February 18, 2019

    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.

    FDA Recall
    Terminated ·Tedan Surgical Innovations Llc·Product code LXH·June 11, 2012

    DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·February 18, 2019

    PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·May 15, 2020

    3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·May 15, 2020

    3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·May 15, 2020

    Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code GEA·July 16, 2019

    PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·May 15, 2020

    PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·May 15, 2020

    PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·May 15, 2020

    PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·May 15, 2020

    D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·February 18, 2019

    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    FDA Recall
    Terminated ·TeDan Surgical Innovations LLC·Product code LXH·February 18, 2019

    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    FDA Enforcement
    Class II ·Terminated·TeDan Surgical Innovations LLC·March 25, 2020

    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

    FDA Enforcement
    Class II ·Terminated·TeDan Surgical Innovations LLC·March 25, 2020