BEUDAMED
    FDA Enforcement Class II Terminated

    Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S

    Recall: Z-1406-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1406-2021
    Event ID
    87530
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centinel Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 21, 2021
    Initiation Date
    March 5, 2021
    Classification Date
    April 9, 2021
    Termination Date
    August 2, 2021
    Address
    900 Airport Rd Ste 3b, N/A, West Chester, PA, 19380-3416, United States

    Description

    Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S

    Reason

    Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.

    Code Info

    UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600

    Distribution

    US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.

    Quantity

    49 devices