BEUDAMED
    FDA Enforcement Class II Terminated

    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

    Recall: Z-2278-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2278-2019
    Event ID
    83372
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    May 29, 2019
    Classification Date
    August 14, 2019
    Termination Date
    January 15, 2021
    Address
    1111 Chomedey (A-13) E, N/A, Laval, N/A, N/A, Canada

    Description

    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

    Reason

    Handle could jam with the Driver due to the detachment of an internal Connector Ring.

    Code Info

    Lot # 150115-09, 160427-01 and A162-02

    Distribution

    CA, DE, FL, IL, NC, NE, NY and TN

    Quantity

    19