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    REJUVENATE MODULAR STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SHELL POROUS WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·May 26, 2017

    ADJUSTING DEVICE GAMMA3 DISTAL TARGETING RIGHT, STATIC

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·May 3, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·September 16, 2014

    ARSTASIS ONE ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS INC.·Product code DYB·May 3, 2011

    MULTIPLE-SEE ATTACHED

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAD·March 24, 2009

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024