Recall Z-1925-2016— Berchtold Corp.
Class II · Terminated
Class II FDA medical device recall by Berchtold Corp., initiated 2016-04-19, terminated 2017-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Berchtold Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-19
- Terminated
- 2017-03-31
- Firm location
- Charleston, SC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.