Z-1925-2016 Class II Terminated

Recalled by Berchtold Corp. — Charleston, SC

Recall Details

Product Type
Devices
Report Date
June 15, 2016
Initiation Date
April 19, 2016
Termination Date
March 31, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
227 units

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.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution

Code Information

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