Orthofix U.s. Llc: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Recall Summary Orthofix U.S. LLC is recalling certain Articulated Minirail Fixator external fixation devices because they have incorrect labels—some M101 models are labeled as M103, some M103 models are labeled as M101, and some M122 models are labeled as M111. These devices are used in orthopedic and trauma surgery to stabilize bones. The recall affects devices distributed across multiple U.S. states.
- Recalling firm
- Orthofix U.S. LLC
- Product
- Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, 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/c1c551bc-6877-47e0-a8bb-6dfb980e9b2a