BEUDAMED
    34 results · 23ms · Sources: EU EUDAMED, US FDA

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    OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 5, 2024

    LOGIC CR TIB INSERT STD, SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 2, 2022

    LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 10, 2025

    LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 18, 2024

    LGC TIBIAL FIT TRAY CEM SZ 4F / 4T

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    LOGIC CR FEMORAL CEM, RIGHT, SZ 4

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    THREE PEG PATELLA 32MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 21, 2023

    LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 18, 2023

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 4, 2024

    LOGIC CR FEMORAL CEM, RIGHT, SZ 3

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 24, 2025

    ONE PEG PATELLA 32MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 23, 2025

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 1, 2024

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574077·CoRoent Ant TLIF Ti, 11x11x40mm 0°

    ABSORBENT, C02, SODALIME

    FDA UDI
    A-M SYSTEMS, LLC·00817081022773·ABSORBENT, C02, SODALIME BAG, 3 LBS

    S-Type baseplate

    FDA UDI
    MACROMEDICS B.V.·08719425700021·S-Type baseplate, 2P

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E89611114000·IRIS Scissors, curved 11,5cm SuperCut one bl...