BEUDAMED
    FDA Recall Terminated

    Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.

    Recall: Z-1473-2020 · Initiated January 28, 2020

    Recall

    Recall Number
    Z-1473-2020
    Event Number
    84928
    FEI Number
    1000432246
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 28, 2020
    Terminated
    March 17, 2023
    Address
    Medicrea International 5389 Route De Strasbourg Vancia Rillieux La Pape France

    Description

    Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.

    Reason

    An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.

    Action

    On January 28, 2020, the firm notified affected customers of the recall via email. Customers were informed that affected lots may include screws which were incorrectly assembled. Customers were instructed to do the following: - Immediately check your internal inventory and quarantine the recalled product. Document results and coordinate with Medicrea International to return any nonconforming devices identified. - Inform all interested/affected parties. - Inform Medicrea International if any of the recalled devices have been distributed to other organizations. Provide contact details so that Medicrea International can inform the recipients appropriately. Distributors are responsible for retrieving the product. -Complete the customer response form attached to the customer notification even if you no longer have any physical inventory on site.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal.

    Quantity

    3529