BEUDAMED
    FDA Recall Terminated

    Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

    Recall: Z-1850-2021 · Initiated May 6, 2021

    Recall

    Recall Number
    Z-1850-2021
    Event Number
    87959
    Firm
    Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
    FEI Number
    3002806725
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 6, 2021
    Terminated
    July 5, 2023

    Description

    Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.

    Reason

    Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

    Action

    Corin initiated the recall by email on 05/06/2021 and followed with a letter on 05/07/2021 disseminated by email. The firm is seeking the return of the product.

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    4 units