BEUDAMED
    FDA Recall Terminated

    Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

    Recall: Z-2070-2017 · Initiated March 27, 2017

    Recall

    Recall Number
    Z-2070-2017
    Event Number
    76868
    FEI Number
    1000118360
    Product Code
    FWM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 27, 2017
    Posted
    May 11, 2017
    Terminated
    June 13, 2017
    Address
    3025 Skyway Cir N, Mentor Texas, LP., Irving, TX, 75038-3524

    Description

    Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

    Reason

    Missing Dome Pack accessory.

    Action

    Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) . Actions Requested If you have already implanted a device from this lot, there is no risk to patient health and you do not need to take any action. Immediately identify all unused units and return them to Mentor per the normal return process.Forward this notice to anyone in your facility that needs to be informed. If you have sent these units to another facility, forward this notice to that facility. Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned. We apologize for any inconvenience this may cause. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter. Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. If you have any questions related to this notice, please contact your local Mentor Sales Representative or Mentor Customer Service at 1-800-235-5731. For further questions please call (972) 252-6060. Thank you for your attention and cooperation.

    Distribution

    US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.

    Quantity

    28 units