BEUDAMED
    FDA Recall Terminated

    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    Recall: Z-0953-2017 · Initiated December 19, 2016

    Recall

    Recall Number
    Z-0953-2017
    Event Number
    76104
    Firm
    In2Bones, SAS 28 Chemin du petit Bois Ecully France
    FEI Number
    3010470577
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 19, 2016
    Posted
    January 6, 2017
    Terminated
    February 1, 2017

    Description

    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    Reason

    Dimensional non-conformity of the thread on the screw head.

    Action

    IN2BONES en a Field Safety Corrective Action letter dated December 15, 2016, to the sole US distributor. The letter identified the product, the problem, and the action to be taken by the customer. We therefore recommend you to follow the instructions here below: 1. Identify all the devices with the batches subject of this recall that might still be in your inventory and quarantine them 2. Inform and distribute this Recall Notification to all relevant persons within your organization 3. To distributors only: Identify all the devices with the batches subject of this recall that were delivered to your customers, and if relevant, instruct them to also follow these instructions (identification and quarantine) 4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to comply with the recommendations listed. This fax back form will enable In2Bones to conduct effectiveness checks. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at +33 4 72 29 26 26 / +33 7 61 88 44 30 or by email: [email protected]. For questions regarding this recall call 844-602-6637.

    Distribution

    Worldwide Distribution - US TN only and Internationally to France and Switzerland

    Quantity

    40 units