BEUDAMED
    74 results · 12ms · Sources: EU EUDAMED, US FDA

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    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-110030120_REV D.pdf.pdf

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code KWS·November 28, 2017

    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 21, 2018

    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE

    FDA Recall
    Terminated ·Enztec Limited 26 Dakota Crescent, Sockburn Christchurch New Zealand·Product code HWA·August 16, 2019

    Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·May 17, 2017

    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

    FDA Recall
    Terminated ·DJO, LLC·Product code JOW·May 28, 2013

    RSP Baseplate Rim Planer (Size 32, 36, 40): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696 The Baseplate Rim Planer is used to prepare the bone around the peripheral rim of the reamed socket. It has a spring loaded alignment pin on the proximal (cutting) end used in both alignment of the planer and as an indication that the planer has been seated fully.

    FDA Recall
    Terminated ·Product code LXH·September 28, 2011

    RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696. The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.

    FDA Recall
    Terminated ·Product code LXH·September 28, 2011

    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE

    FDA Enforcement
    Class II ·Terminated·Enztec Limited·February 3, 2021

    Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.

    FDA Recall
    Terminated ·Invacare Corporation·Product code INI·December 7, 2011

    CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.

    FDA Recall
    Terminated ·Product code HWB·November 10, 2010

    Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).

    FDA Recall
    Terminated ·Greatbatch Medical·Product code HTQ·April 23, 2017

    DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.

    FDA Recall
    Terminated ·Product code JWH·December 12, 2017

    FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.

    FDA Recall
    Terminated ·Djo Surgical·Product code LPH·February 7, 2014

    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

    FDA Recall
    Terminated ·DJO, LLC·Product code IMJ·August 21, 2015

    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.

    FDA Recall
    Terminated ·DJO, LLC·Product code IMF·June 25, 2018

    EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

    EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical

    FDA Recall
    Terminated ·Product code KWS·November 5, 2010

    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical

    FDA Recall
    Terminated ·Product code KWS·November 5, 2010

    Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical

    FDA Recall
    Terminated ·Product code KWS·November 5, 2010