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

FDA Device Recall #Z-1925-2016 — Class II — April 19, 2016

Recall Summary

Recall Number Z-1925-2016
Classification Class II — Moderate risk
Date Initiated April 19, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Berchtold Corp.
Location Charleston, SC
Product Type Devices
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

Lot / 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

Other Recalls from Berchtold Corp.

Recall # Classification Product Date
Z-0154-2016 Class II TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 ser... Sep 23, 2015
Z-1488-2013 Class II Hand Controls for Operon D750, D752, D760, D820... Mar 12, 2013
Z-2148-2012 Class III Chromovision High Definition (HD) Wireless Came... Jul 10, 2012
Z-2168-2013 Class II OPERON D850 Surgical Table Product Usage: S... Apr 16, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.