Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Orthofix U.S. LLC
The hazard
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 FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model All LotsModel GTIN# 18032568866681UPC 18032568866681Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.