BEUDAMED
    FDA Recall Terminated

    Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.

    Recall: Z-0849-06 · Initiated March 8, 2006

    Recall

    Recall Number
    Z-0849-06
    Event Number
    35046
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    GXL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 8, 2006
    Posted
    May 6, 2006
    Terminated
    June 26, 2008
    Address
    125 Cremona Dr, Goleta, CA, 93117-5503

    Description

    Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.

    Reason

    Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.

    Action

    Medtronic Neurosurgery sent a Sales Representative Notification letter to the applicable Medtronic Sales Representative by mail and fax on March 8, 2006. A Sales Representative Notification Letter was provided to each Medtronic Sales Representative who had received the product or is responsible for an account who has received the product. This letter informed the applicable Sales Representative of the action and instructed them how to complete the Sales Representative Customer Product Accountability Letter. A Sales Representative Customer Product Accountability Letter was provided to each Medtronic Sales Representative who has received the product or is responsible for an account who has received the product. This letter requests the current product status, i.e., has the product been used, discarded or will it be returned to Medtronic Neurosurgery. Each letter will be individualized for each customer indicating the specific catalog number(s), lot number(s) and quantity that were shipped to that customer. It is the firm''s intention to have the Sales Representative exchange all affected product with replacement product during this process.

    Distribution

    The product was distributed to the following states: Florida, Illinois, New York, Pennsylvania, Tennessee

    Quantity

    60