BEUDAMED
    FDA Recall Open, Classified

    Fixone Biocomposite Anchor

    Recall: Z-1167-2026 · Initiated December 17, 2025

    Recall

    Recall Number
    Z-1167-2026
    Event Number
    98312
    Firm
    Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)
    FEI Number
    3014232239
    Product Code
    MAI
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 17, 2025
    Posted
    January 26, 2026

    Description

    Fixone Biocomposite Anchor

    Reason

    Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

    Action

    An URGENT MEDICAL DEVICE RECALL notice dated 12/17/25 was mailed to consignees. The notification instructs consignees to discontinue use of affected devices, segregate affected devices, and return the product to Aju Pharm Medical or the authorized distributor. If product was further distributed the recall notification is to be forwarded for their awareness. Aju Pharm states that no additional action is required for patients who have already undergone surgery using affected devices. Consignees with any questions should contact +82-02-2630-0641 by phone or [email protected].

    Distribution

    US Nationwide distribution in the states of CA & PR.

    Quantity

    1,088 units