BEUDAMED
    FDA Enforcement Class II Ongoing

    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

    Recall: Z-1317-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1317-2023
    Event ID
    91869
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Limacorporate S.p.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2023
    Initiation Date
    February 21, 2023
    Classification Date
    March 30, 2023
    Address
    Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, N/A, Italy

    Description

    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

    Reason

    Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.

    Code Info

    UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30

    Distribution

    US: MO

    Quantity

    1