BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1056-2022 · Initiated April 14, 2022

    Recall

    Recall Number
    Z-1056-2022
    Event Number
    90015
    Firm
    Cerapedics, Inc.
    FEI Number
    3007155473
    Product Code
    NOX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 14, 2022
    Terminated
    December 23, 2024
    Address
    11025 Dover St, Unit 1600, Westminster, CO, 80021-5574

    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.

    Action

    On 04/14/2022, Cerapedics, Inc. email a "Medical Device Recall" letter to customer informing them that the firm is voluntarily recalling all units of i-FACTOR 1.0cc Putty from lot 21C0991 due to the incorrect product code on the patient chart label. Customers are asked to: 1) Examine their inventory and return any remaining units from lot 21C0991 using the provided RMA number. 2) Respond to the Recall email or call toll free at 1-866-360-5612 to report the number of units at their location. 3) If the affected product has been further distributed, notify those customers of the recall utilizing the recall notification letter. Questions or assistance - contact Customer Service at 1-866-360-5612.

    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