BEUDAMED
    29 results · 28ms · Sources: EU EUDAMED, US FDA

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    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

    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

    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

    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

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

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

    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 Enforcement
    Class II ·Terminated·Djo Surgical·March 12, 2014

    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

    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

    Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical

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

    AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, LP·October 28, 2020

    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·August 15, 2012

    Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·April 17, 2019

    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

    FDA Recall
    Terminated ·Product code HWC·July 16, 2012

    EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.

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

    EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.

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

    EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

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

    Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and a functional deltoid muscles in necessary to use the device.

    FDA Recall
    Terminated ·Product code KWS·April 18, 2011