BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

    Recall: Z-0120-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0120-2020
    Event ID
    83774
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    August 28, 2019
    Classification Date
    October 10, 2019
    Termination Date
    July 23, 2020
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR

    Reason

    A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.

    Code Info

    Batch/Lot: 2019061801

    Distribution

    Nationwide

    Quantity

    1530 each