BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.

    Recall: Z-1819-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1819-2013
    Event ID
    65068
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2013
    Initiation Date
    March 28, 2013
    Classification Date
    July 29, 2013
    Termination Date
    October 24, 2013
    Address
    1140 Parsippany Blvd Ste 201, N/A, Parsippany, NJ, 07054-1887, United States

    Description

    Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.

    Reason

    On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.

    Code Info

    Catalog Number 048545; Lot Number L363

    Distribution

    Nationwide Distribution including Nebraska and Virginia.

    Quantity

    18 units