BEUDAMED
    FDA Recall Terminated

    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200

    Recall: Z-0463-2021 · Initiated October 8, 2020

    Recall

    Recall Number
    Z-0463-2021
    Event Number
    86657
    Firm
    Medicrea International Vancia Vancia Rillieux La Pape France
    FEI Number
    1000432246
    Product Code
    OWI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 8, 2020
    Terminated
    May 9, 2024

    Description

    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200

    Reason

    Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,

    Action

    Medicrea International issued Reportable voluntary Recall notification dated 10/5/20 to via e-mail to distributors and subsidiaries stating reason for recall, health risk and action to take: Instructions sent to US subsidiary : 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organisations. a) Please provide contact details so that MEDICREA can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. 4. Please inform MEDICREA of any adverse events concerning the use of the subject devices Please comply with any local laws or regulations concerning the notification of adverse events to your National Competent Authority. 5. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore please complete even if you no longer have any of the subject devices in your physical inventory. Contact: Karine TROGNEUX MEDICREA INTERNATIONAL Regulatory Affairs Manager, Direct : +33(0)4.69.85.95.39 Standard : +33 (0)4.72.01.87.87. Fax - N +33 (0)04 72 01 87 88 Mail : [email protected]

    Distribution

    CA Foreign:France, Belgium

    Quantity

    17 units US; 8 units OUS Expanded: 1 US and 3 OUS