Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
USOrthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Recalling Firm: Orthofix U.S. LLC
Reason for Recall / Hazard
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
Product Description & Identification
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Affected Products
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Additional Source Details
| Field | Value |
|---|---|
| City | Lewisville |
| State | TX |
| Event id | 99225 |
| Address 1 | 3451 Plano Pkwy |
| Code info | All Lots; GTIN# 18032568866636; |
| Postal code | 75056-9453 |
| Report date | 20260722 |
| Product type | Devices |
| Product quantity | 48 units |
| 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260610 |
| Initial firm notification | |
| Center classification date | 20260714 |
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Overview
- Recalling FirmOrthofix U.S. LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS: 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
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🚨 SAFETY ALERT: Orthofix U.S. LLC - Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device Check if your household is affected: https://therecallfile.com/recalls/orthofix-minirail-standard-lengthener-model-catalog-number-m101-unilat/FDA-Z-2729-2026
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