BEUDAMED
    FDA Enforcement Class II Ongoing

    PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010

    Recall: Z-1165-2026 · Reported February 4, 2026

    Enforcement

    Recall Number
    Z-1165-2026
    Event ID
    98242
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cerapedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 4, 2026
    Initiation Date
    December 29, 2025
    Classification Date
    January 23, 2026
    Address
    11025 Dover St Unit 1600, N/A, Westminster, CO, 80021-5574, United States

    Description

    PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010

    Reason

    Incorrect expiration date

    Code Info

    Lot: 7014819/UDI: (01)00850001680196

    Distribution

    US Nationwide distribution in the states of CA, CO, CT, FL, GA, ID, IL, KS, LA, MI, MN, MO, MT, NE, NJ, NV, NY, OH,OR, PA, TN, TX, WA, WY.

    Quantity

    237 units