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U.S. Department of Health and Human Services

Class 2 Device Recall Orthofix MINIRAIL , STANDARD LENGTHENER

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 Class 2 Device Recall Orthofix MINIRAIL , STANDARD LENGTHENERsee related information
Date Initiated by FirmJune 10, 2026
Date PostedJuly 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2729-2026
Recall Event ID 99225
510(K)NumberK113770 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductOrthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Code Information All Lots; GTIN# 18032568866636;
FEI Number 2183449
Recalling Firm/
Manufacturer		 Orthofix U.S. LLC
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactOrthofix Complaints
214-937-2000
Manufacturer 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
FDA Determined
Cause 2		Process change control
ActionOn June 8, 2026, Orthofix issued a Urgent Medical Device Recall Notification, via E.Mail. Orthofix asked consignees to take the following actions: 1.Discontinue use of the affected product lots immediately. 2.Immediately examine your inventory and quarantine any affected product and return them to Orthofix. 3. Complete the attached response form and return it to Orthofix. 4. This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred.
Quantity in Commerce48 units
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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KTT
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