BEUDAMED
    FDA Recall Open, Classified

    . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

    Recall: Z-1101-2025 · Initiated January 10, 2025

    Recall

    Recall Number
    Z-1101-2025
    Event Number
    96047
    Firm
    Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden
    FEI Number
    3002807692
    Product Code
    DZE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 10, 2025
    Posted
    February 5, 2025

    Description

    . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

    Reason

    Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

    Action

    On 01/10/2025, the firm emailed an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Nobel Biocare became aware through internal quality control one of the plastic components of the packaging that is used to hold the OsseoShaper in place may contain a manufacturing error. This results in a sharp edge that could puncture the blister packaging, thereby breaching the sterile barrier. Customers and Distributors are instructed to: 1. Inspect their stock and quarantine affected devices. The use of affected devices should be ceased immediately. 2. For Distributors, complete attached Distributor Acknowledgement Form with information collected from end user and return the firm to Nobel Biocare via email to [email protected] with in 5 days of receipt of this notice. 2. Complete attached Customer Acknowledgment Form, even if customers do not have any affected stock, and return it to Nobel Biocare, via email to [email protected], within 5 days of receipt of this notice. 3. Return all affected stock on hand to Nobel Biocare using the shipping label attached to this notice. 4. Ensure relevant staff members are informed of this recall. If products were supplied or transferred to another facility or organization, inform these facilities of the recall by providing a copy of this notice. For question or further support, contact local customer support representative at 800-322-5001 ext. 1527 or at [email protected]

    Distribution

    U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.

    Quantity

    1,558 units (90 units - U.S.)