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Terminated

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.

FDA Recall Z-1925-2016 · Posted 2016-06-07

Recalling FirmBerchtold Corp.
Recall StatusTerminated
Product CodeLWG
Date Initiated2016-04-19
Date Terminated2017-03-31
Product Quantity227 units

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.

Firm Action

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 [email protected] and then discard the HybiGel Pads.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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