BEUDAMED
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    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 Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·September 4, 2013

    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018

    System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·February 18, 2015

    Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 29, 2015

    Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·November 11, 2015

    Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·September 2, 2015

    Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·August 15, 2012

    Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-170.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

    Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive,

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·January 2, 2013

    Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-180.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

    Stryker SmartLife Large Aseptic Housing (7126-120-000)

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 3, 2017

    Stryker Instruments Minor modification product, 550-19-20 with 304.8mm length, sterile, product of Ireland, Stryker Instruments, Kalamazoo, MI; REF 5500019020S3.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·January 1, 2014

    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·January 1, 2014

    Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·November 14, 2018

    Stryker PainPump ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-10.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700

    FDA Enforcement
    Class I ·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012

    Stryker Instruments 6.5mm Round Fluted Bur Extra Long for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-65.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

    Stryker Instruments 7.0mm Round Fluted Bur Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-70.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·January 10, 2008

    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 19, 2015