BEUDAMED
    FDA Enforcement Class II Terminated

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)

    Recall: Z-0438-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0438-2021
    Event ID
    86526
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merete Medical GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 18, 2020
    Initiation Date
    September 18, 2020
    Classification Date
    November 6, 2020
    Termination Date
    May 13, 2021
    Address
    Alt-Lankwitz 102, Berlin, N/A, Germany

    Description

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)

    Reason

    Product may be mislabeled.

    Code Info

    Lot Number Use By Date MS1912994R 6/4/2025 MS1811555R 7/24/2025 MS1913023R 6/4/2025 MS1811556R 7/24/2025 MS1913024R 6/4/2025 MS1913024R 6/4/2025 MS1811557R 7/24/2025 MS1913027R 6/4/2025 MS1811585R 7/23/2025 MS1913028R 6/4/2025 MS1811604R 7/23/2025 MS1913029R 6/4/2025 MS1913029R 6/4/2025 MS1811605R 7/23/2025 MS1913038R 6/4/2025 MS1811606R 7/23/2025 MS1811607R 6/4/2025 MS1811607R1 7/23/2025 MS1913039R 6/4/2025 MS1811624R 7/23/2025 MS1811673R 6/4/2025 MS1811625R 7/23/2025 MS1811673R1 7/23/2025 MS1811634R 6/4/2025 MS1811634R1 7/23/2025 MS1913041R 6/4/2025 MS1811623R 7/24/2025 MS1913042R 6/4/2025 MS1811635R 7/24/2025 MS1913043R 6/4/2025 MS1913043R 6/4/2025 MS1811636R 7/24/2025

    Distribution

    Product was distributed in US - CA, IL, MD, OH, and NJ

    Quantity

    144 units