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    PRIMA CUSTOM ANESTESIA CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127027734·Adapter, Threaded Cup Impactor

    Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 4, 2007

    Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 4, 2007

    EVO platform

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPY Cystoscope/Hysteroscope

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 7, 2011

    BARD FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 15, 2014

    NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. " Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024