BEUDAMED
    FDA Recall Completed

    TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

    Recall: Z-1667-2022 · Initiated July 12, 2022

    Recall

    Recall Number
    Z-1667-2022
    Event Number
    90662
    Firm
    Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
    FEI Number
    3002806725
    Product Code
    JDI
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    July 12, 2022

    Description

    TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

    Reason

    Some of the devices did not pass fatigue testing.

    Action

    The recalling firm issued the recall letter dated 7/8/2022 via email to the consignee on 7/12/2022. The recall letter described the potential issue and listed the affected product. The potential risk was reported and the actions to be carried out by the customer, which included return of the product from the field and completion of the acknowledgement form to be returned via email to confirm receipt of the letter.

    Distribution

    Distribution was made to NJ. There was no military/government distribution.

    Quantity

    1