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 because they have incorrect model labels—for example, some M101 models are labeled as M103 and vice versa. These devices are used in orthopedic and trauma surgery to stabilize bones during healing. The recall affects devices distributed across 29 U.S. states.
- Recalling firm
- Orthofix U.S. LLC
- Product
- Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, 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/8205b45e-7afa-4d57-90f2-e112686f7edf