Z-1925-2016 Class II Terminated
FDA device recall Z-1925-2016 was initiated by Berchtold Corp. on April 19, 2016 and is designated Class II. 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. The recall status is terminated (terminated March 31, 2017). Affected quantity: 227 units.
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