BEUDAMED
    FDA Enforcement Class II Terminated

    P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

    Recall: Z-2261-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2261-2018
    Event ID
    80181
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Paragon 28, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2018
    Initiation Date
    December 19, 2017
    Classification Date
    June 20, 2018
    Termination Date
    January 15, 2021
    Address
    4B Inverness Ct E Ste 280, N/A, Englewood, CO, 80112-5329, United States

    Description

    P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

    Reason

    Missing drill guide as stated in the package.

    Code Info

    Part # P71-008-0808-S 8mm x 8mm x 8mm, Straight Lots 260315217A, 260322017A, 260326217A and 260326217B., Part # P71-010-1010-S 10mm x 10mm x 10mm, Straight Lots 260317717A, 260317717C, 260322017B, and 260326217D., Part # P71-108-0808-S 8mm x 8mm x 8mm, Angled, Lots 260322017C, 260322017D, 260315217B, and 260326217M. and Part # P71-110-1010-S 10mm x 10mm x 10mm, Angled Lots 260326217E, 260317717B, 260322017E, 260322017F, 260322017G, 260326217F and 260326217G.

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.

    Quantity

    1,626