Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- Orthofix U.S.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Orthofix U.S.
- Product type
- PTC Spacer System
- Model numbers
- Lot Code: All Lots/ UDI: 37-3106SP 18257200030590 37-3107SP 18257200030613 37-3108SP 18257200030637 37-3109SP 18257200030651 37-3110SP 18257200030675 37-3111SP 18257200030699 37-3112SP 18257200030712 37-3113SP 18257200030736 37-3114SP 18257200030750 37-3006SP 18257200030415 37-3007SP 18257200030439 37-3008SP 18257200030453 37-3009SP 18257200030477 37-3010SP 18257200030491 37-3011SP 18257200030514 37-3012SP 18257200030538 37-3013SP 18257200030552 37-3014SP 18257200030576 37-3207SP 18257200146352 37-3208SP 18257200146369 37-3209SP 18257200146376 37-3210SP 18257200146383 37-3211SP 18257200146390 37-3212SP 18257200146406 37-4106SP 18257200030958 37-4107SP 18257200030972 37-4108SP 18257200030996 37-4109SP 18257200031016 37-4110SP 18257200031030 37-4111SP 18257200031054 37-4112SP 18257200031078 37-4113SP 18257200031092 37-4114SP 18257200031115 37-4006SP 18257200030774 37-4007SP 18257200030798 Part Number GTIN 37-4008SP 18257200030811 37-4009SP 18257200030835 37-4010SP 18257200030859 37-4011SP 18257200030873 37-4012SP 18257200030897 37-4013SP 18257200030910 37-4014SP 18257200030934 37-4207SP 18257200146420 37-4208SP 18257200146437 37-4209SP 18257200146444 37-4210SP 18257200146451 37-4211SP 18257200146468 37-4212SP 18257200146475 37-5106SP 18257200031313 37-5107SP 18257200031337 37-5108SP 18257200031351 37-5109SP 18257200031375 37-5110SP 18257200031399 37-5111SP 18257200031412 37-5112SP 18257200031436 37-5113SP 18257200031450 37-5114SP 18257200031474 37-5006SP 18257200031139 37-5007SP 18257200031153 37-5008SP 18257200031177 37-5009SP 18257200031191 37-5010SP 18257200031214 37-5011SP 18257200031238 37-5012SP 18257200031252 37-5013SP 18257200031276 37-5014SP 18257200031290 37-5207SP 18257200146505 37-5208SP 18257200146512 37-5209SP 18257200146529 37-5210SP 18257200146536 37-5211SP 18257200146543 37-5212SP 18257200146550
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling contains claims that are not consistently present.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The CONSTRUX Mini PTC Spacer System is used in medical settings for spinal support and adjustments. Consumers purchase these devices for their potential to aid in orthopedic treatments.
Why This Is Dangerous
The labeling inconsistencies can lead to confusion about the correct usage of the device, impacting patient safety and treatment effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product immediately, which may affect ongoing treatments. The need for a refund process can also pose an inconvenience.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled list.
- Verify the lot code to determine if your device is affected.
- Contact your healthcare provider for assistance.
Where to find product info
Look for the model number and lot code printed on the device packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement to take approximately 4-6 weeks once your request is processed.
If the manufacturer is unresponsive
- Document all communication attempts with Orthofix.
- Consider reaching out to the FDA for assistance.
- Keep records of your purchase and correspondence.
How to prevent similar issues
- Look for FDA approval when purchasing medical devices.
- Always read labels and instructions carefully.
- Consult with healthcare professionals about device safety.
Documentation advice
Keep records of your correspondence with the manufacturer, including emails and receipts.
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Product Details
The recall includes the CONSTRUX Mini PTC Spacer System with model numbers 37-3106SP through 37-5212SP. The products measure 12mm or 15mm in width and vary in height from 6mm to 14mm. These devices were distributed worldwide, including across the United States and several countries.
Key Facts
- Recall date: November 3, 2025
- Quantity recalled: 61,977 units
- Affected model numbers: 37-3106SP to 37-5212SP
- Labeling claims inconsistent
- No reported injuries or incidents
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Safety Guide
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