BEUDAMED
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    Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400010 CPT 12/14 COCR SIZE 0 EXT 811400000 CPT 12/14 COCR SIZE 0 STD 811400110 CPT 12/14 COCR SIZE 1 EXT 811400100 CPT 12/14 COCR SIZE 1 STD 811400210 CPT 12/14 COCR SIZE 2 EXT 811400200 CPT 12/14 COCR SIZE 2 STD 811400230 CPT 12/14 COCR SIZE 2 XEX 811400310 CPT 12/14 COCR SIZE 3 EXT 811400300 CPT 12/14 COCR SIZE 3 STD 811400330 CPT 12/14 COCR SIZE 3 XEX 811400410 CPT 12/14 COCR SIZE 4 EXT 811400400 CPT 12/14 COCR SIZE 4 STD 811400430 CPT 12/14 COCR SIZE 4 XEX 811400510 CPT 12/14 COCR SIZE 5 EXT 811400500 CPT 12/14 COCR SIZE 5 STD 811400530 CPT 12/14 COCR SIZE 5 XEX For use in total or hemi hip arthroplasty

    FDA Recall
    Terminated ·Product code JDI·January 11, 2016

    Product 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG 801100222 CPT MOD HD ST/ST 22MED SH 801100322 CPT MOD HD ST/ST 22MMD LN 801100122 CPT MOD HD ST/ST 22MMD SH 801100126 CPT MOD HD ST/ST 26MMD SH 801100328 CPT MOD HD ST/ST 28MMD LN 801100228 CPT MOD HD ST/ST 28MMD ME 801100128 CPT MOD HD ST/ST 28MMD SH 801100332 CPT MOD HD ST/ST 32MMD LN 801100232 CPT MOD HD ST/ST 32MMD ME 801100132 CPT MOD HD ST/ST 32MMD SH 801100100 CPT MODULAR STEM SIZE 1 S 801100200 CPT MODULAR STEM SIZE 2 S 801100300 CPT MODULAR STEM SIZE 3 S 801100400 CPT MODULAR STEM SIZE 4 S 801100500 CPT MODULAR STEM SIZE 5 S For use in total or hemi hip arthroplasty

    FDA Recall
    Terminated ·Product code JDI·January 11, 2016

    Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400 12/14 UNIPOLAR FEMORAL HE 781804500 12/14 UNIPOLAR FEMORAL HE 781804600 12/14 UNIPOLAR FEMORAL HE 781804700 12/14 UNIPOLAR FEMORAL HE 781804800 12/14 UNIPOLAR FEMORAL HE 781804900 12/14 UNIPOLAR FEMORAL HE 781805000 12/14 UNIPOLAR FEMORAL HE 781805100 12/14 UNIPOLAR FEMORAL HE 781805200 12/14 UNIPOLAR FEMORAL HE 781805300 12/14 UNIPOLAR FEMORAL HE 781805400 12/14 UNIPOLAR FEMORAL HE 781805500 12/14 UNIPOLAR FEMORAL HE 781806300 12/14 UNIPOLAR FEMORAL HE 781809900 12/14 UNIPOLAR FEMORAL HE 781809901 12/14 UNIPOLAR FEMORAL HE 781809902 12/14 UNIPOLAR FEMORAL HE Product For use in total or hemi hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE For use in total or hemi hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GDJ·June 29, 2018

    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013

    rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GDJ·June 29, 2018

    rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code JDB·November 8, 2005

    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDB·June 24, 2015

    Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017

    Smith & Nephew Grasper, Cupped 3.4mm REF: 011014

    FDA Recall
    Terminated ·Smith & Nephew, Inc., Endoscopy Div.·Product code GDJ·April 6, 2005

    Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDB·June 24, 2015

    rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017