BEUDAMED
    FDA Enforcement Class II Ongoing

    POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

    Recall: Z-1534-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1534-2024
    Event ID
    94237
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SURGICAL SPECIALTIES
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 24, 2024
    Initiation Date
    March 26, 2024
    Classification Date
    April 12, 2024
    Address
    247 Station Dr, Westwood, MA, 02090-2396, United States

    Description

    POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

    Reason

    Complaints have been received with allegations of Incorrect Needle Curvature.

    Code Info

    Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;

    Distribution

    Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.

    Quantity

    2,459 units