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Trigon
NVision Biomedical Technologies, Inc. · Model LD-050208T-28 · UDI-DI 00810005669672
FZX
Prescription
10
510(k) clearances
8,555
Adverse events (4 deaths)
29
Recalls
526
Facilities
Description
5mm (2° Sagittal 8° Transverse) Lapidus Wedge . The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-30 | Waldemar Link GmbH & Co. KG (Mfg Site) | Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resec |
| 2022-10-10 | Hologic, Inc | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2019-08-21 | Zimmer Biomet, Inc. | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| 2018-03-26 | Zimmer Biomet, Inc. | Potential failure of sterile packaging seal. |
| 2017-08-07 | Synthes, Inc. | May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is dr |
| 2017-04-25 | Cook Inc. | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products |
| 2016-08-09 | Zimmer Biomet, Inc. | Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targ |
| 2016-06-07 | Synthes (USA) Products LLC | DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified |
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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.