BEUDAMED
    FDA Enforcement Class II Ongoing

    Speed Stitch Needle Cassette

    Recall: Z-2999-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-2999-2020
    Event ID
    86290
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ArthroCare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2020
    Initiation Date
    August 17, 2020
    Classification Date
    September 21, 2020
    Address
    7000 W William Cannon Dr Bldg 1, N/A, Austin, TX, 78735-8509, United States

    Description

    Speed Stitch Needle Cassette

    Reason

    Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

    Code Info

    Model: OM-8850 Lot Numbers: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239 & 2032526

    Distribution

    Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV. International Distribution: AE, AU, CH, DE, FI, FR, GB, HK, IE, PA, PR, PT, RU, SG, and ZA

    Quantity

    6,366 needles