Reported Jun 15, 2016 · Terminated

Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads…

Berchtold Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Berchtold Corp. · 1950 Hanahan Rd · Charleston, SC · 29406-4878

Is this the product you have?

  • 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.
Lot codes and dates
    • 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
Amount recalled
227 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 31, 2017 · Data as of Sep 19, 5:18 PM UTC

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