Z-2732-2026 Class II Ongoing
FDA device recall Z-2732-2026 was initiated by Orthofix U.S. LLC on June 10, 2026 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 62 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- June 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units
Product Description
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Reason for Recall
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
Distribution Pattern
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
Code Information
All Lots; GTIN# 18032568866711