BEUDAMED
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    3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.

    FDA Recall
    Terminated ·Product code JWH·March 19, 2010

    AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·April 4, 2018

    FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.

    FDA Recall
    Terminated ·Product code JWH·August 4, 2008

    AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.

    FDA Recall
    Terminated ·Product code PHX·January 30, 2018

    Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem.

    FDA Recall
    Terminated ·Product code HTQ·April 21, 2011

    FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 Metric Blvd., Austin, TX 78758 The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.

    FDA Recall
    Terminated ·Product code JDI·August 17, 2011

    Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·August 31, 2016

    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

    Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·November 9, 2016

    Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·December 21, 2016

    3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·May 8, 2013

    6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·October 31, 2012

    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·September 5, 2012

    FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·August 5, 2015

    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·November 4, 2015

    AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·January 20, 2016

    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·November 4, 2015

    Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·December 14, 2016

    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·September 6, 2017

    EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·November 1, 2017