BEUDAMED
    FDA Enforcement Class II Ongoing

    DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile

    Recall: Z-0453-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0453-2022
    Event ID
    89117
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medshape, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 12, 2022
    Initiation Date
    November 17, 2021
    Classification Date
    January 4, 2022
    Address
    1575 Northside Dr Nw Ste 440, N/A, Atlanta, GA, 30318-4211, United States

    Description

    DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile

    Reason

    The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.

    Code Info

    Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060

    Distribution

    Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.

    Quantity

    26 units (1 count)