BEUDAMED
    47 results · 24ms · 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.
    Filters Status: Terminated ×

    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·November 22, 2017

    ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625

    FDA Recall
    Terminated ·Integra Biotechnical LLC·Product code FRO·February 1, 2007

    BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code PLF·April 22, 2016

    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HRS·January 11, 2016

    Arthrex Suture Washer

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HTN·August 12, 2016

    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HSX·October 3, 2017

    Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples, Florida United States The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries

    FDA Recall
    Terminated ·W & H DentalWerk Buermoos GMBH 53 Ignaz-Glazer-Strasse Burmoos Austria·Product code HWE·May 24, 2011

    Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code GFF·January 14, 2019

    Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HRS·June 24, 2020

    Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code MAI·March 24, 2017

    Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code MAI·March 24, 2017

    Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HWC·October 1, 2019

    Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code MAI·March 24, 2017

    Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code MAI·March 24, 2017

    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HTW·February 24, 2021