FDA recall Z-2729-2026

Product

Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, 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

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

Key facts

Status

Ongoing

Initiation date

2026-06-10

Report date

2026-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lewisville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2729-2026