Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may
FDA device recall Z-1925-2016 · posted 2016-06-07 · Terminated
Recall details
- Recalling firm
- Berchtold Corp.
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LWG
- Quantity affected
- 227 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-04-19
- Date posted
- 2016-06-07
- Date terminated
- 2017-03-31
- Location
- Charleston, SC
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