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

Recall date

April 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1925-2016

FDA classification

Class II

Brand / firm

Berchtold Corp.

Sold / distributed

Nationwide Distribution

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.