BEUDAMED
    FDA Recall Terminated

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    Recall: Z-2488-2015 · Initiated July 29, 2015

    Recall

    Recall Number
    Z-2488-2015
    Event Number
    71862
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    MDI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 29, 2015
    Posted
    August 31, 2015
    Terminated
    August 18, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    Reason

    The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require surgury to exchange components. Effects may also include pain, loss of deformity correction, and/or soft tissue/visceral injury.

    Action

    Urgent recall letters, dated July 29, 2015, were sent to end users alerting them to the problem, the associated risk to patients, and provided instruction to return affected devices withthe response form.

    Distribution

    Worldwide distribution including US nationwide, Canada and Germany.

    Quantity

    3262