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 labels—devices labeled as model M103 are actually M101, M101 devices are labeled as M103, and M122 devices are labeled as M111. The affected devices were distributed across multiple U.S. states. This is classified as a Class II recall.
- Recalling firm
- Orthofix U.S. LLC
- Product
- Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, 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/028d21a4-1f48-4301-9b85-fe5252fdc5f7