BEUDAMED
    FDA Enforcement Class II Terminated

    Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.

    Recall: Z-0372-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0372-2017
    Event ID
    75288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Schaerer Medical USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 16, 2016
    Initiation Date
    September 27, 2016
    Classification Date
    November 8, 2016
    Termination Date
    July 17, 2020
    Address
    675 Wilmer Ave, Cincinnati, OH, 45226-1802, United States

    Description

    Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.

    Reason

    The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. The cylinders were manufactured with the incorrect "O" ring which may cause the cylinder to leak.

    Code Info

    Lot code of the replacement cylinders, 2016-02-01

    Distribution

    Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed

    Quantity

    10 replacement cylinders.