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TrenGuard™
Dan Allen Surgical LLC · Model 56401 · UDI-DI 10811836030232
8
510(k) clearances
783
Adverse events (2 deaths)
7
Recalls
285
Facilities
Description
TrenGuard 600 HYBRID Wedge Packs - Each 4-piece Pack contains: Wedge "Speed Bump" Bolster and Head Stabilizing Pillow. For use with Reusable Lateral Stabilizing Pillows as part of HYBRID system. Weight limit up to 250 kg. Case of 12 ea. 00811836030235 (model #56481)
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.