BEUDAMED
    FDA Recall Terminated

    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

    Recall: Z-1976-2013 · Initiated May 30, 2013

    Recall

    Recall Number
    Z-1976-2013
    Event Number
    65777
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 30, 2013
    Posted
    August 22, 2013
    Terminated
    December 30, 2014
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

    Reason

    Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

    Action

    Stryker Spine sent a 'Urgent Medical Device Removal Letter'/'Customer Response Form' to Branch Managers, Agent Principals, Quality Contacts, Hospital OR Risk Managers, OR supervisor on 5/30/2013 via Fed Ex. Inventory should be examined and returned.The attached form should be completed and returned as well. Stryker Spine sent 'Urgent Medical Device Removal Letters' to Spinal Implant Surgeons on 6/20/2013 via Fed Ex.

    Distribution

    Nationwide Distribution.

    Quantity

    1536 units (US) 880 (Foreign)