BEUDAMED
    FDA Recall Open, Classified

    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

    Recall: Z-0581-2025 · Initiated October 29, 2024

    Recall

    Recall Number
    Z-0581-2025
    Event Number
    95654
    Firm
    Smith & Nephew Inc.
    FEI Number
    3003604053
    Product Code
    MBI
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    October 29, 2024
    Posted
    November 29, 2024
    Address
    150 Minuteman Rd, Andover, MA, 01810-1031

    Description

    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

    Reason

    Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

    Action

    An URGENT MEDICAL DEVICE RECALL NOTICE dated 10/29/24 was mailed to consignees. This notification instructed consignees to inspect their inventory for affected devices and quarantine them immediately. If product was further distributed consignees are to notify their customers of this recall and ensure recall actions are completed. Consignees are to complete the provided response form to facilitate the return of devices and email the completed form to [email protected]. Consignees who do not have product on hand are to complete and return the recall response form as well. Any questions about this recall are to be emailed to [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

    Quantity

    2,156 units