BEUDAMED
    33 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    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

    MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·July 27, 2016

    Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·February 15, 2017

    RSP Impaction Fixture

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·March 15, 2017

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

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·January 17, 2018

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

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·January 17, 2018