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Class 2 Device Recall Surgical Table Cushion (HybriGel Pads) |
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Date Initiated by Firm |
April 19, 2016 |
Date Posted |
June 07, 2016 |
Recall Status1 |
Terminated 3 on March 31, 2017 |
Recall Number |
Z-1925-2016 |
Recall Event ID |
73999 |
Product Classification |
Surgical table cushion - Product Code LWG
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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. |
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 |
Recalling Firm/ Manufacturer |
Berchtold Corp. 1950 Hanahan Rd Charleston SC 29406-4878
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For Additional Information Contact |
Nicole Kubat 972-410-7226
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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.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
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 ComRecallCoordinator@stryker.com and then discard the HybiGel Pads. |
Quantity in Commerce |
227 units |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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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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