BEUDAMED
    FDA Enforcement Class I 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 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1976-2013
    Event ID
    65777
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    May 30, 2013
    Classification Date
    August 22, 2013
    Termination Date
    December 30, 2014
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    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.

    Code Info

    K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above

    Distribution

    Nationwide Distribution.

    Quantity

    1536 units (US) 880 (Foreign)