BEUDAMED
    FDA Enforcement Class II Terminated

    PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

    Recall: Z-1975-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1975-2021
    Event ID
    87971
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SPINEART SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 7, 2021
    Initiation Date
    April 9, 2021
    Classification Date
    June 28, 2021
    Termination Date
    September 29, 2022
    Address
    Chemin Du Pre-Fleuri 3, N/A, Plan-Les-Ouates, N/A, N/A, Switzerland

    Description

    PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

    Reason

    Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

    Code Info

    Reference Number/Product Description/Batch Number: -TLF-LC OP 15-S / PERLA TL Lateral Connector Open, 15mm / 5-2983 -TLF-LC OP 30-S / PERLA TL Lateral Connector Open, 30mm / 5-2993

    Distribution

    U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided

    Quantity

    44 units in the U.S.