BEUDAMED
    FDA Enforcement Class II Terminated

    Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.

    Recall: Z-1925-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1925-2016
    Event ID
    73999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Berchtold Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    April 19, 2016
    Classification Date
    June 7, 2016
    Termination Date
    March 31, 2017
    Address
    1950 Hanahan Rd, N/A, Charleston, SC, 29406-4878, United States

    Description

    Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.

    Reason

    The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray.

    Code Info

    141364, 141365, 141367, 141369, 142575, 142577, 142579, 142769, 142771, 142773, 142774, 142775, 143420, 144088, 144384, 144447, 145384, 145529, 145545, 145936, 146141, 146963, 147304, 147305, 147306

    Distribution

    Nationwide Distribution

    Quantity

    227 units