FDA (Devices) recall action 99225
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Unilateral 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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.