BEUDAMED
    FDA Enforcement Class III Terminated

    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

    Recall: Z-2038-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2038-2020
    Event ID
    85531
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    April 3, 2020
    Classification Date
    May 15, 2020
    Termination Date
    November 20, 2020
    Address
    1111 Chomedey (A-13) E, N/A, Laval, N/A, N/A, Canada

    Description

    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

    Reason

    The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.

    Code Info

    SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.

    Distribution

    US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.

    Quantity

    3 units