BEUDAMED
    FDA Recall 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 · Initiated June 29, 2020

    Recall

    Recall Number
    Z-2777-2020
    Event Number
    85946
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 29, 2020
    Terminated
    February 18, 2022
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    The firm sent a letter to customers dated 06/29/2020 and titled "Urgent Medical Device Recall Notice". The letter informs customers of a field action to voluntarily remove a single lot of PeriLoc Targeters due to a manufacturing error. Customers should inspect their inventory and locate any devices from the listed product and batch numbers enclosed with the Recall Notice, and quarantine them immediately. Sales reps or distributors, should notify customers of the field action and ensure that the required actions are complete. Customers should completed a form identifying if they have product to return or no product to return. Customers returning product should list batches and quantities that are being returned. Completed forms should be signed and send to [email protected]. The firm's contact information: [email protected]. T: + 1 901 396 2121 T: 1 800 821 5700 (USA toll free)

    Distribution

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

    Quantity

    3 units