BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0437-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0437-2021
    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 (tibia)

    Reason

    Product may be mislabeled.

    Code Info

    Lot number Use By Date MS1913183R 5/12/2025 MS1811576R 7/22/2025 MS1913047R 6/3/2025 MS1811577R 7/22/2025 MS1913048R 6/3/2025 MS1811578R 7/22/2025 MS1913048R1 7/22/2025 MS1913049R 6/3/2025 MS1913049R 6/3/2025 MS1811579R 7/22/2025 MS1913050R 6/3/2025 MS1913050R 6/3/2025 MS1811580R 7/22/2025 MS1913051R 6/3/2025 MS1811581R 7/22/2025 MS1912629R 6/3/2025 MS1811650R 7/22/2025 MS1912633R 6/3/2025 MS1912633R 6/3/2025 MS1811651R 7/22/2025 MS1913077R 6/3/2025 MS1913077R 6/3/2025 MS1811608R 7/22/2025 MS1913078R 6/3/2025 MS1811609R 7/22/2025 MS1913079R 6/3/2025 MS1811652R 7/22/2025 MS1913080R 6/3/2025 MS1811653R 7/22/2025 MS1912634R 6/3/2025 MS1912634R 6/3/2025 MS1811654R 7/22/2025 MS1912634R1 7/22/2025 MS1913032R 6/3/2025 MS1811610R 7/22/2025 MS1913030R 6/3/2025 MS1811637R 7/22/2025 MS1913031R 6/3/2025 MS1811655R 7/22/2025 MS1912635R 5/26/2025 MS1912635R 5/26/2025 MS1912635R1 7/22/2025 MS1811656R 7/22/2025 MS1912632R 6/3/2025 MS1912632R 6/3/2025 MS1912632R1 7/22/2025 MS1811657R 7/22/2025

    Distribution

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

    Quantity

    215 units