BEUDAMED
    FDA Enforcement Class II Terminated

    Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.

    Recall: Z-0127-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0127-2014
    Event ID
    66456
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    November 4, 2013
    Classification Date
    November 1, 2013
    Termination Date
    April 29, 2014
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.

    Reason

    Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m

    Code Info

    Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.

    Distribution

    Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.

    Quantity

    20,385 total distributed since 2004