Recall Z-1925-2016 ยท LWG Surgical Table Cushion
Berchtold Corp.
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.
| Date | Jun 7, 2016 (initiated Apr 19, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 227 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.