BEUDAMED
    FDA Enforcement Class II Ongoing

    Artelon FlexBand Plus Ref: 41054 & 41057

    Recall: Z-1555-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1555-2026
    Event ID
    98399
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    International Life Sciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2026
    Initiation Date
    February 6, 2026
    Classification Date
    March 11, 2026
    Address
    8601 Dunwoody Pl Ste 250, N/A, Atlanta, GA, 30350-2513, United States

    Description

    Artelon FlexBand Plus Ref: 41054 & 41057

    Reason

    Augmentation devices failed bacterial endotoxin testing.

    Code Info

    REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.

    Quantity

    N/A