BEUDAMED
    FDA Recall Terminated

    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

    Recall: Z-2207-2020 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2207-2020
    Event Number
    85331
    Firm
    Nobel Biocare Usa Llc
    FEI Number
    1000125598
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 19, 2019
    Terminated
    October 27, 2020
    Address
    22715 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4609

    Description

    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

    Reason

    The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

    Action

    Customers who received product/affected lot were to be contacted via Urgent Medical Device Recall Letter dated July 18, 2019 via USPS on July 19, 2019. In addition to informing customers about the recall, the recall notification asked customer to take the following actions: 1. Identify affected devices in your stock by confirming the information on the side label: NobelActive Internal NP 3.5x15mm, article 34128, lot 13080792. 2. Confirm the information on the top label as shown in figure 1 above. 3. Complete attached Customer Acknowledgment Form and return it to Nobel Biocare, via email to [email protected] or fax 714-282-5073, within 5 days of receipt of this letter. 4. Return incorrectly labeled products (top label 3.5x11.5) to: Nobel Biocare Attn: Returns PFA1917 22715 Savi Ranch Pkwy Yorba Linda, CA 92887 . 5. Correctly labeled products (top label 3.5x15) do not need to be returned. 6. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x.1527.

    Distribution

    US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None

    Quantity

    221 implants