BEUDAMED
    FDA Recall Terminated

    Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

    Recall: Z-1988-2015 · Initiated June 8, 2015

    Recall

    Recall Number
    Z-1988-2015
    Event Number
    71428
    Firm
    Allergan Inc
    FEI Number
    2011068
    Product Code
    MRD
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 8, 2015
    Posted
    July 7, 2015
    Terminated
    December 16, 2015
    Address
    2525 Dupont Dr, Irvine, CA, 92612-1531

    Description

    Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.

    Reason

    Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.

    Action

    A recall letter dated 6/8/15 was sent to all customers who received the NATRELLE 410 cc Re-Sterilizable Breast Implant Sizer. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST. On June 12, 2015, Actavis sent follow up letters to customers to include one additional serial number.

    Distribution

    CA, IN, MO, NJ, VA

    Quantity

    9 units