BEUDAMED
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    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.

    FDA Recall
    Terminated ·Coltene Whaledent Inc·Product code EJL·April 13, 2018

    Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

    FDA Recall
    Terminated ·Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil·Product code EJL·December 23, 2019

    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

    FDA Recall
    Terminated ·Coltene Whaledent AG Feldwiesenstrasse 20 Altstatten Sg Switzerland·Product code EJL·July 19, 2019

    BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code EJL·February 16, 2009

    SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.

    FDA Recall
    Terminated ·Hager & Meisinger Gmbh Hansemannstr. 10 Neuss Germany·Product code EJL·July 15, 2020

    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

    FDA Recall
    Terminated ·Cardiac Assist, Inc·Product code DWF·November 19, 2019

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

    FDA Recall
    Terminated ·Alcon Research, LTD.·Product code OGO·August 28, 2018

    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

    FDA Recall
    Terminated ·Alcon Research, LTD.·Product code OGO·August 28, 2018

    CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.

    FDA Recall
    Terminated ·Alcon Research, LTD.·Product code OGO·August 28, 2018

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.

    FDA Recall
    Terminated ·Alcon Research, LTD.·Product code OGO·August 28, 2018

    Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HRS·November 18, 2010

    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HRS·August 22, 2011

    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017

    Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.

    FDA Recall
    Terminated ·Biomet 3i, Inc.·Product code EJB·May 9, 2008

    SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USA SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic

    FDA Recall
    Terminated ·CIBA Vision Puerto Rico, Inc. El Jibaro·Product code LPL·February 1, 2011

    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 5830 El Camino Real·Product code NKB·October 5, 2016

    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 5830 El Camino Real·Product code NKB·May 5, 2017

    SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

    FDA Recall
    Terminated ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code ISM·October 25, 2016

    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Recall
    Terminated ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code PGQ·October 16, 2018

    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Recall
    Terminated ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code PGQ·October 16, 2018