BEUDAMED
    FDA Recall 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 · Initiated April 19, 2016

    Recall

    Recall Number
    Z-1925-2016
    Event Number
    73999
    Firm
    Berchtold Corp.
    FEI Number
    1220685
    Product Code
    LWG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 19, 2016
    Posted
    June 7, 2016
    Terminated
    March 31, 2017
    Address
    1950 Hanahan Rd, Charleston, SC, 29406-4878

    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.

    Action

    Berchtold Corporation sent an Urgent Medical Device Recall letter dated April 19, 2016, to all affected customers. The consignees were instructed to return the enclosed acknowledgment form by email to [email protected] and then discard the HybiGel Pads.

    Distribution

    Nationwide Distribution

    Quantity

    227 units