BEUDAMED
    FDA Recall Terminated

    Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

    Recall: Z-0538-2018 · Initiated October 9, 2017

    Recall

    Recall Number
    Z-0538-2018
    Event Number
    78936
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 9, 2017
    Posted
    January 18, 2018
    Terminated
    August 6, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

    Reason

    Wrong device description of the label identifying the implant

    Action

    Exactech sent an Urgent Medical Device Recall letter dated October 9, 2017, informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions, please call (800) 392-2832.

    Distribution

    US Distribution to the states of : AL, CA, CO, FL, MD. and NY

    Quantity

    34