BEUDAMED
    FDA Enforcement Class II Ongoing

    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

    Recall: Z-0655-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0655-2020
    Event ID
    84178
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CP Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 18, 2019
    Initiation Date
    October 18, 2019
    Classification Date
    December 6, 2019
    Address
    1775 Corporate Dr Ste 150, N/A, Norcross, GA, 30093-2960, United States

    Description

    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

    Reason

    Failed to meet USP minimum average value for knot pull (tensile) strength.

    Code Info

    Product Code: 494A/494A-IMC; Lot Number: 190123-59; date of manufacture: 03/04/2019

    Distribution

    USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE

    Quantity

    174 boxes 12 per box (plus 36 samples) - total of 2124 sutures