BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1534-2024 · Initiated March 26, 2024

    Recall

    Recall Number
    Z-1534-2024
    Event Number
    94237
    Firm
    SURGICAL SPECIALTIES
    FEI Number
    3016050589
    Product Code
    GAM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 26, 2024
    Posted
    April 12, 2024
    Address
    247 Station Dr, Westwood, MA, 02090-2396

    Description

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

    Reason

    Complaints have been received with allegations of Incorrect Needle Curvature.

    Action

    On March 26, 2024 customers were sent URGENT MEDICAL DEVICE RECALL letters via email. The letters instructed customers to immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of the product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter and the acknowledgement form for product return. We kindly request the return of any affected product that may still be in your stock inventory, and we will replace the product at no charge. If you have any questions, contact [email protected].

    Distribution

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

    Quantity

    2,459 units