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Orthofix U.S. LLC
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Type Company Card addedAugust 10 Threat lists flagged Reviews1
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Threat lists · flagged Product safety recall
Official safety regulators published alerts about a product of this kind.
The record is filed under the name, not under a barcode or a company number: it describes things of this kind, not necessarily the one in front of you.
Alerts on record13 HazardUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 First alertFebruary 20, 2025 Latest alertJune 10, 2026 On our lists sinceAugust 10, 2026
What to do: Check the maker, the batch and the date of the exact item you have — the alert is about this kind of product.
Where this came from: openFDA device recalls — An official government safety register — product recalls and safety alerts.
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Reviews · 1
Orthofix U.S. LLC is part of the orthopaedic and spine world, where the real customers are surgeons, hospitals, and clinics that need implants, fixation devices, and related surgical products. By our assessment, its strongest point is that it belongs to a field where concrete engineering matters: screws, plates, biologics, and spine hardware are judged by whether they do the job in the operating room. The downside is the obvious one for this kind of company: the business is narrow, highly specialised, and tied to procedures that most people only encounter when something has gone wrong. In practice that means long sales cycles, clinical scrutiny, and products that must fit strict use cases rather than broad consumer demand. It sits in a crowded medical-device segment alongside larger orthopaedic names, so it is more a specialist supplier than a household healthcare brand. Orthofix U.S. LLC is for professionals who need surgical tools and implants with a very specific job, not for anyone looking for general medical equipment. The ceiling is the same as the category itself: technical utility first, visibility never.
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