BEUDAMED
    FDA Enforcement Class II Completed

    PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

    Recall: Z-1481-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1481-2022
    Event ID
    90493
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2022
    Initiation Date
    April 1, 2020
    Classification Date
    July 29, 2022
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

    Reason

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

    Code Info

    UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.

    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

    3392