BEUDAMED
    FDA Enforcement Class II Terminated

    EasyFuse Dynamic Compression System Instrument Pack

    Recall: Z-0853-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0853-2022
    Event ID
    89739
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2022
    Initiation Date
    March 10, 2022
    Classification Date
    March 31, 2022
    Termination Date
    April 1, 2026
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    EasyFuse Dynamic Compression System Instrument Pack

    Reason

    The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

    Code Info

    Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)

    Distribution

    US distribution to Florida, North Carolina, Ohio, and Texas

    Quantity

    176 packs