BEUDAMED
    FDA Enforcement Class II Ongoing

    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

    Recall: Z-1078-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1078-2024
    Event ID
    93790
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer Surgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    January 2, 2024
    Classification Date
    February 13, 2024
    Address
    200 W Ohio Ave, N/A, Dover, OH, 44622-9642, United States

    Description

    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

    Reason

    Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.

    Code Info

    UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)

    Distribution

    Worldwide - US Nationwide distribution including in the states of CA, DE, FL, GA, IA, IL, IN, KS, LA, MI, MO, MT, NC, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV and the countries of AUTRALIA, CANADA, DNIPRO OBLAS, HONG KONG, INDIA, JAPAN, MEXICO, CDMX, NETHERLANDS, SEOUL KOREA, SINGAPORE, TAIWAN, THAILAND.

    Quantity

    76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS