FDA Device recall Z-2732-2026
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device by Orthofix U S, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2732-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-10 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Orthofix U S |
| Distribution | 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 |
Product
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, 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
Identifiers
| code_info | All Lots; GTIN# 18032568866711 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2732-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.