BEUDAMED
    FDA Recall Completed

    PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

    Recall: Z-1482-2022 · Initiated April 1, 2020

    Recall

    Recall Number
    Z-1482-2022
    Event Number
    90493
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    KOA
    Status
    Completed
    Root Cause
    Process change control
    Initiated
    April 1, 2020
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

    Reason

    Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

    Action

    A notification letter was issued April 30, 2020 sent USPS Certified mail . The notification identifies the products as Catalog Item # 8360-10 PRESTIGE ATRA GRASPER DBL-ACT 5MM and 8361-10 PRESTIGE RETR GRASPER DBL-ACT 5MM. Customers were to evaluate inventory with a "tug test" and submit the notification acknowledgment form. Should a device fail the tug test, customers were to file a complaint using Aesculap's Online Customer Complaint Submission Form and return a the product. The products have since been discontinued.

    Distribution

    United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.

    Quantity

    399