BEUDAMED
    FDA Recall Open, Classified

    Speed Stitch Needle Cassette

    Recall: Z-2999-2020 · Initiated August 17, 2020

    Recall

    Recall Number
    Z-2999-2020
    Event Number
    86290
    Firm
    ArthroCare Corporation
    FEI Number
    3010813691
    Product Code
    HXK
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 17, 2020
    Address
    7000 W William Cannon Dr, Bldg 1, Austin, TX, 78735-8509

    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.

    Action

    On August 17,2020 the firm notified all its consignees via letter of the field action. They provided the following instructions: Please inspect your inventory and locate any devices from the listed product and batch numbers, and quarantine them immediately. " If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. If you have no product to return, please put an X in the appropriate location. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes. Complete the remainder of the form, sign and send to [email protected] or fax to +1-901-566-7975.

    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