BEUDAMED
    FDA Enforcement Class II Terminated

    PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

    Recall: Z-2777-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2777-2020
    Event ID
    85946
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 19, 2020
    Initiation Date
    June 29, 2020
    Classification Date
    August 10, 2020
    Termination Date
    February 18, 2022
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

    Reason

    The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.

    Code Info

    Product Number: 71173400, Lot Number: 16GM20026

    Distribution

    U.S Nationwide including in the states of IN and TN.

    Quantity

    3 units