BEUDAMED
    FDA Recall Terminated

    Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

    Recall: Z-2162-2018 · Initiated May 1, 2018

    Recall

    Recall Number
    Z-2162-2018
    Event Number
    80112
    Firm
    Keystone Dental Inc
    FEI Number
    3005990499
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 1, 2018
    Terminated
    September 14, 2018
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403

    Description

    Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

    Reason

    The implants are mislabeled.

    Action

    The Firm sent an Urgent Medical Device Correction letter dated April 30, 2018. In this discrepancy, the 5 is missing from the implant length description. Please note this discrepancy is limited to the implant package label only. The patient chart labels are all correct. Keystone Dental has performed a thorough review and determined there are no health hazards associated with this issue. There is no issue with the product within the package and the product can be safely used without issue in accordance with the defined surgical protocols. There is no risk of confusion of product size. The diameter is correct. Prima Plus implants are only available in 11.5mm lengths. The catalogs, surgical protocols and manuals only define procedures and provide instrumentation for placing 11.5mm length implants. Additionally, the patient chart labels contained within the implant package are correct so that patient procedure history will be properly maintained. The issue is limited to the label on the outside of the product package only. The lot identified above is the only affected lot. No other lots are affected with this issue. The product referenced above can be used safely without issue and no further action is required. For further questions, please call (866) 902-9272.

    Distribution

    US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.

    Quantity

    72