Events

Recall of Surgical Table Cushion (HybriGel Pads)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Berchtold Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73999
  • Event Risk Class
    Class 2
  • Event Number
    Z-1925-2016
  • Event Initiated Date
    2016-04-19
  • Event Date Posted
    2016-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145874
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgical table cushion - Product Code LWG
  • 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 ComRecallCoordinator@stryker.com and then discard the HybiGel Pads.

Device

Surgical Table Cushion (HybriGel Pads)
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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.
  • Manufacturer
    Berchtold Corp.

Manufacturer

Berchtold Corp.
  • Manufacturer Address
    Berchtold Corp., 1950 Hanahan Rd, Charleston SC 29406-4878
  • Manufacturer Parent Company (2017)
    Berchtold Corporation
  • Source
    USFDA