Manufacturer
13 recalls in our database name Orthofix U.S. LLC as the manufacturing or recalling firm.
Of the 13 recalls from Orthofix U.S. LLC we have scored against our rubric, 1 (8%) 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.
Orthofix U.S. LLC is recalling 19 units of Orthofix MINIRAIL orthopedic external fixation devices distributed across the US due to incorrect model labeling that could lead to surgical use of the wrong device.
Orthofix U.S. LLC is recalling Articulated Minirail Fixator external fixation devices due to incorrect model labeling. Three models were mislabeled: M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111.
Orthofix U.S. LLC is recalling Orthofix MINIRAIL external fixation devices (Model M101) because they may be labeled with incorrect model numbers, potentially leading to use of wrong device specifications.
Orthofix MINIRAIL unilateral external fixation devices may be labeled with incorrect model numbers. Three model variants (M101, M103, M122) were mislabeled during manufacturing.
Chetak New York is recalling Deep-brand frozen surti undhiu mix after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Orthofix U.S. is recalling 14,201 Forza Ti Spacer System units because the labeling contains claims that are not consistently present.
Orthofix U.S. is recalling 13,317 Pillar SA PTC Spacer System units because the labeling contains claims that are not consistently present.
Orthofix U.S. is recalling 61,977 CONSTRUX Mini PTC Spacer System units because the labeling contains claims that are not consistently present.
Orthofix U.S. is recalling 19,431 FIREBIRD SI Fusion System units because the labeling contains claims that are not consistently present.
Orthofix U.S. is recalling 40,956 CONSTRUX Mini Ti Spacer System units because the labeling contains claims that are not consistently present.
Orthofix is recalling 624 Virata preassembled polyaxial screws used in the Virata Spinal Fixation System because the screws do not meet performance standards.
PILLAR SA Ti sterile 37 mm intervertebral body fusion devices are recalled because the outer and inner label side flaps state an incorrect width of 33 mm. 3 units are affected.
Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.