BEUDAMED
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    UNIT, CRYOSURGICAL, ACCESSORIES

    FDA Adverse Event
    Injury ·BTG YOKNEAM·Product code GEH·May 27, 2020

    Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JWH·September 11, 2009

    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·November 14, 2012

    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JDI·October 13, 2008

    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code LZO·November 15, 2017

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KRO·May 19, 2017

    Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KWS·November 4, 2019

    MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

    FDA Recall
    Completed ·Medacta Usa Inc·Product code OVD·March 8, 2023

    MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

    FDA Recall
    Completed ·Medacta Usa Inc·Product code OVD·March 8, 2023

    Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code MEH·January 15, 2010

    MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device

    FDA Recall
    Completed ·Medacta Usa Inc·Product code OVD·March 8, 2023

    Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patients condition should be due to one or more of: " Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis. " Avascular necrosis of the femoral head. " Acute traumatic fracture of the femoral head or neck. " Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. " Dislocation risks.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code MEH·May 23, 2011

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code LXH·April 13, 2022

    NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code OLO·October 27, 2022

    MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

    FDA Recall
    Completed ·Medacta Usa Inc·Product code OVD·March 8, 2023

    MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device

    FDA Recall
    Completed ·Medacta Usa Inc·Product code OVD·March 8, 2023

    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code MEH·December 17, 2012

    Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code FWX·May 21, 2008

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JWH·October 24, 2017

    Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KWP·December 7, 2016