BEUDAMED
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    Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies. Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 3, 2018

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Enforcement
    Class II ·Terminated·Vascular Technology, Inc.·July 16, 2014

    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·April 21, 2021

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HRS·March 11, 2021

    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·March 22, 2017

    Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies. Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HSB·July 30, 2018

    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.

    FDA Recall
    Terminated ·Acumed LLC·Product code LXH·February 17, 2017

    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXT·January 29, 2016

    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 16, 2016

    Hemashield Gold Woven and Knitted Double Vascular Grafts.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010

    AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

    FDA Recall
    Terminated ·LeMaitre Vascular, Inc.·Product code MAL·June 17, 2013

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020

    Hemashield Platinum Woven Double Velour TAAA Vascular Grafts.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010

    AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

    FDA Recall
    Terminated ·LeMaitre Vascular, Inc.·Product code MAL·June 17, 2013

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020

    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MAL·April 7, 2020