Drug recall
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table…
FDA recall event 73999 · Class II · Berchtold Corp.
Key facts
| Event ID | 73999 |
|---|---|
| Recall numbers | Z-1925-2016 |
| Recalling firm | Berchtold Corp. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 19, 2016 |
| Report date | Jun 15, 2016 |
| Termination date | Mar 31, 2017 |
| City | Charleston |
| State | SC |
| Country | United States |
| FEI number | 1220685 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: