BEUDAMED
    FDA Recall 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 · Initiated April 9, 2021

    Recall

    Recall Number
    Z-1975-2021
    Event Number
    87971
    Firm
    SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland
    FEI Number
    3007728266
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 9, 2021
    Terminated
    September 29, 2022

    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.

    Action

    On 04/12/2021, the firm sent an email to its US Distribution Center and a follow-up "URGENT: MEDICAL DEVICE RECALL" letter (dated April 14, 2021) TO inform customers that the recall was being initiated due to an external labelling error where the external labels were mixed-up for two batches and could lead to confusion for the hospital staff and induce a minimal surgery delay. Customers are instructed to: 1. Immediately review their inventory and quarantine concerned products if any. 2. If they may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Sent back all products with the enclosed Response Form to Spineart Geneva (Chemin du Pr Fleuri 3, 1228 Plan-les-Ouates, Switzerland). E-mail: [email protected]. 5. All returned products will be exchanged with batches already available in our warehouse.

    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.