BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0453-2022 · Initiated November 17, 2021

    Recall

    Recall Number
    Z-0453-2022
    Event Number
    89117
    Firm
    Medshape, INC.
    FEI Number
    3007593722
    Product Code
    HWC
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 17, 2021
    Address
    1575 Northside Dr Nw, Ste 440, Atlanta, GA, 30318-4211

    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.

    Action

    The firm indicated that they will send recall notification to sales representatives via email or certified mail. Customers will be instructed to remove all +6 mm endcaps from stock and to return to the recalling firm with a return label that will be provided at a later date. Customers with questions are to contact the recalling firm at (678)235-3314.

    Distribution

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

    Quantity

    26 units (1 count)