BEUDAMED
    FDA Enforcement Class III Terminated

    putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

    Recall: Z-1056-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1056-2022
    Event ID
    90015
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cerapedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 18, 2022
    Initiation Date
    April 14, 2022
    Classification Date
    May 10, 2022
    Termination Date
    December 23, 2024
    Address
    11025 Dover St Unit 1600, N/A, Westminster, CO, 80021-5574, United States

    Description

    putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

    Reason

    Patient chart label contains incorrect Part Number and volume amount.

    Code Info

    Model/Catalog Number: 700-010 UDI Code: (01)00850001680004(17)240531(10)21C0991 Lot Number: 21C0991

    Distribution

    U.S. Nationwide distribution in the states of AL, AZ, CA, CT, DC, DE, ID, IN, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, TX, VA, and WA.

    Quantity

    572 units