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Recall Observatory FDA recall evidence

Device 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.

Z-1925-2016

April 19, 2016

Class II

Product summary

Firm
Berchtold Corp.
Event
Event 73999
Status
Terminated
Classification
Class II
Quantity
227 units
Official record key
device-enforcement:Z-1925-2016

Official wording

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.

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

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.