FDA-Device2016-06-15Class II
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.
Berchtold Corp.
Hazard
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.
Sold states
Nationwide Distribution
Affected count
227 units
Manufactured in
1950 Hanahan Rd, N/A, Charleston, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2016Don't want to check this manually?
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