BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1317-2023 · Initiated February 21, 2023

    Recall

    Recall Number
    Z-1317-2023
    Event Number
    91869
    Firm
    Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy
    FEI Number
    3008021110
    Product Code
    MBF
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 21, 2023
    Posted
    April 1, 2023

    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.

    Action

    On 2/21/23, a recall notice was distributed to a customer who was asked to do the following: 1) Check your stock to locate and quarantine the affected devices. Devices must be sent back. 2) Complete, and return the response form to [email protected] 3) The recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Inquiries can be sent to [email protected]

    Distribution

    US: MO

    Quantity

    1