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TrenGuard™
Dan Allen Surgical LLC · Model 54812 · UDI-DI 00811836030846
8
510(k) clearances
783
Adverse events (2 deaths)
7
Recalls
285
Facilities
Description
TrenGuard 600 Solo Wedge Packs - 12 each disposable packs (each pack includes one wedge bolster).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2021-07-23 | Aspen Surgical Products, Inc. | Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the |
| 2014-05-08 | Covidien LLC | Straps may separate from the foam pad. |
| 2011-11-16 | Allen Medical Systems, Inc. | C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity |
| 2007-11-27 | Allen Medical Systems, Inc. | Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.