BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2278-2019 · Initiated May 29, 2019

    Recall

    Recall Number
    Z-2278-2019
    Event Number
    83372
    Firm
    Pega Medical Inc. 1111 Chomedey (A-13) E Laval Canada
    FEI Number
    3000327445
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 29, 2019
    Terminated
    January 15, 2021

    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.

    Action

    An e-mail was sent on May 25, 2019 to all their consignees with the following instructions. Identify the device with the same catalogue number and lot number and return the device to Pega Medical Inc. as soon as possible to the address shown below using the FedEx Account number provided. Contact Enrique Garcia at (450) 688-5144 ext. 242 or [email protected] for more information

    Distribution

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

    Quantity

    19