BEUDAMED
    FDA Recall Terminated

    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

    Recall: Z-2828-2020 · Initiated July 20, 2020

    Recall

    Recall Number
    Z-2828-2020
    Event Number
    86085
    Firm
    NOBEL BIOCARE SERVICES AG Balz-zimmermannstrasse 7 Kloten Switzerland
    FEI Number
    3008693672
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 20, 2020
    Terminated
    May 12, 2021

    Description

    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

    Reason

    Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.

    Action

    On 07/20/20, Urgent Medical Device Recall notices were emailed to customers who were asked to do the following: 1. Inspect your stock and confirm that both the cap label and the vial label indicate 4.3x10mm. 2. Quarantine devices with cap label 5.0x8mm. 3. Complete attached Customer Acknowledgment Form, even if you do not have any affected stock, and return it to the recalling firm via email. 4. Return all incorrectly labeled devices to the firm. Correctly labeled devices do not need to be returned. 5. Ensure relevant staff members are informed of this recall. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall by providing a copy of this letter. 6. Firm will replace returned affected devices. If you require any further information or support, please contact your local customer support representative at 714-282-4800 ext. 1527.

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.

    Quantity

    188