BEUDAMED
    FDA Recall Terminated

    DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.

    Recall: Z-1319-2015 · Initiated March 9, 2015

    Recall

    Recall Number
    Z-1319-2015
    Event Number
    70736
    Firm
    In2Bones, SAS 28 Chemin Du Petit Bois Ecully France
    FEI Number
    3010470577
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 9, 2015
    Posted
    March 25, 2015
    Terminated
    May 19, 2016

    Description

    DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.

    Reason

    Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

    Action

    The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product.

    Distribution

    Distributed in the state of TN.

    Quantity

    15 units