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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Table Cushion (HybriGel Pads)

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 Class 2 Device Recall Surgical Table Cushion (HybriGel Pads)see related information
Date Initiated by FirmApril 19, 2016
Date PostedJune 07, 2016
Recall Status1 Terminated 3 on March 31, 2017
Recall NumberZ-1925-2016
Recall Event ID 73999
Product Classification Surgical table cushion - Product Code LWG
ProductSurgical 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.
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
FEI Number 1220685
Recalling Firm/
Manufacturer		 Berchtold Corp.
1950 Hanahan Rd
Charleston SC 29406-4878
For Additional Information ContactNicole Kubat
972-410-7226
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBerchtold 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.
Quantity in Commerce227 units
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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