Orthofix U.S. LLC — Class II: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/
Orthofix U.S. LLC has initiated a Class II recall for certain Minirail unilateral external fixation devices due to mislabeling. Model M101 was incorrectly labeled as M103, M103 was labeled as M101, and M122 was labeled as M111.
Orthofix U.S. LLC, orthopedic surgical facilities, sterile processing departments, and regulatory/quality teams managing unilateral external fixation devices.
The transposition of model numbers introduces significant risks for procedural errors, potentially leading to the selection of an incorrect device length or specification during surgery. This suggests a failure in the labeling verification or packaging process, necessitating an investigation into the point of origin for these labeling discrepancies.
Immediately verify existing inventory for the specified model numbers against labeling specifications. Conduct a reconciliation of labeling processes to identify where transposition occurred, and review current labeling verification procedures for external fixation components.
Class II. 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. Product: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device. Firm: Orthofix U.S. LLC (Lewisville TX United States). Status: Ongoing.
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