BEUDAMED
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    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.

    FDA Enforcement
    Class II ·Terminated·Small Bone Innovations, Inc.·June 11, 2014

    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.

    FDA Recall
    Terminated ·Small Bone Innovations, Inc.·Product code KTT·April 7, 2014

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·January 18, 2017

    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

    FDA Enforcement
    Class II ·Terminated·Small Bone Innovations·August 6, 2014

    Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.

    FDA Enforcement
    Class II ·Terminated·Small Bone Innovations, Inc.·November 6, 2013

    SOMATOM CT System Sensation Open. Computed tomography x-ray system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·March 9, 2006

    SOMATOM CT System Sensation 16. Computed tomography x-ray system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·March 9, 2006

    SOMATOM CT System Emotion 16. Computed tomography x-ray system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·March 9, 2006

    SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·March 9, 2006

    Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imager)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MQB·February 15, 2012

    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUE·February 28, 2013

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    Fujifilm FDR Go Plus mobile X-ray system

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code IZL·July 19, 2019

    Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.

    FDA Recall
    Terminated ·Sunrise Medical (US) LLC·Product code IOR·July 27, 2015

    Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.

    FDA Recall
    Terminated ·Sunrise Medical (US) LLC·Product code IOR·July 27, 2015

    Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    FDA Recall
    Terminated ·Integra York PA, Inc·Product code LRW·October 28, 2016

    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    FDA Recall
    Terminated ·Integra York PA, Inc·Product code GEN·October 28, 2016

    StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 15, 2013

    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

    FDA Recall
    Terminated ·Small Bone Innovations·Product code HWC·May 19, 2014

    Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.

    FDA Recall
    Terminated ·Small Bone Innovations, Inc.·Product code KWI·September 6, 2013