BEUDAMED
    FDA Recall Terminated

    The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal.

    Recall: Z-0438-2011 · Initiated July 12, 2010

    Recall

    Recall Number
    Z-0438-2011
    Event Number
    56215
    Firm
    Ascension Orthopedics, Inc
    FEI Number
    3002788818
    Product Code
    KYI
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 12, 2010
    Posted
    November 22, 2010
    Terminated
    June 30, 2011
    Address
    8700 Cameron Rd, Ste 100, Austin, TX, 78754

    Description

    The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M, Catalog #NUG-443-40M, Lot #10-0469, is a single-use uncemented, one-component prosthesis for the basal thumb joint. The NuGrip is intended to replace the proximal end of the first metacarpal.

    Reason

    Two different product lots were found to be incorrectly labeled and placed into the incorrect box.

    Action

    Ascension Orthopedics notified by phone on June 25, 2010 and sent a letter dated July 22, 2010, to all customers. The customers were instructed to return the devices to the firm. Should you have any questions or concerns please feel free to contact (512) 836-5001 ext 1585.

    Distribution

    Worldwide distribution: USA including states of: IL, IN, MD, OH, and TN; and countries of : Puerto Rico and Netherlands.

    Quantity

    10