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.
This recall has been terminated (originally issued June 7, 2016).
- Company
- Berchtold Corp.
- Recall Initiated
- April 19, 2016
- Posted
- June 7, 2016
- Terminated
- March 31, 2017
- Recall Number
- Z-1925-2016
- Quantity
- 227 units
- Firm Location
- Charleston, SC
- Official Source
- View on FDA website ↗
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
Nationwide Distribution
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
Berchtold Corporation sent an Urgent Medical Device Recall letter dated April 19, 2016, to all affected customers. The consignees were instructed to return the enclosed acknowledgment form by email to ComRecallCoordinator@stryker.com and then discard the HybiGel Pads.