Orthofix U.s. Llc: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Recall Summary Orthofix U.S. LLC is recalling certain MINIRAIL external fixation devices used in orthopedic and trauma surgery because they have incorrect labeling—some M101 models are labeled as M103, M103 models are labeled as M101, and M122 models are labeled as M111. The devices were distributed across multiple U.S. states. This is classified as a Class II recall, meaning the mislabeling could potentially cause adverse health effects.
- Recalling firm
- Orthofix U.S. LLC
- Product
- Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
- Reason
- 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
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-10
- Status
- Open, Classified
- Areas affected
- AZ, CA, CO, CT, FL, GA, ID, IL, LA, MD, MI, MS, ...
- Distribution
- US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9c8c7e65-9419-427c-8565-6c49040b4e4a