BEUDAMED
    FDA Recall Terminated

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    Recall: Z-3000-2020 · Initiated February 21, 2019

    Recall

    Recall Number
    Z-3000-2020
    Event Number
    85321
    Firm
    ArthroCare Corporation
    FEI Number
    3010813691
    Product Code
    GAT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 21, 2019
    Terminated
    August 17, 2022
    Address
    7000 W William Cannon Dr, Bldg 1, Austin, TX, 78735-8509

    Description

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    Reason

    The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.

    Action

    On February 21, 2019, the firm sent an "Urgent Medical Device Recall Notice" via Federal Express and E-Mail to all affected consignees. In addition to providing information on the recall product the firm asked consignees to take the following actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected] or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. 6. If you have any questions or concerns regarding this recall please contact [email protected].

    Distribution

    US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, SC, SG, TN, TX, UT, VA, WA, WI, WV OUS: Austria, Belgium, Canada, Switzerland, Germany, Denmark, France, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)

    Quantity

    15,559 units