Manufacturer
3 recalls in our database name Blue Ortho as the manufacturing or recalling firm.
Of the 3 recalls from Blue Ortho we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.
Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.
Blue Ortho is recalling TKA Pro v2.1 software installed on the Exactech GPS system because it displays incorrect navigated values due to software inconsistencies.