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 Lot Codes/ UDI: 39-9012SP 18257200112630 39-9014SP 18257200112647 39-9016SP 18257200112654 39-9018SP 18257200112661 39-9212SP 18257200112678 39-9214SP 18257200112685 39-9216SP 18257200112692 39-9218SP 18257200112708 39-2012SP 18257200112715 39-2014SP 18257200112722 39-2016SP 18257200112739 39-2018SP 18257200112746 39-2212SP 18257200112753 39-2214SP 18257200112760 39-2216SP 18257200112777 39-2218SP 18257200112784
- 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 Pillar PTC Spacer System is a medical device used in orthopedic procedures to support bone healing and alignment. Healthcare providers typically use these implants during surgeries to improve patient outcomes.
Why This Is Dangerous
The recall is due to inconsistent labeling claims that could mislead healthcare providers and patients about the device's intended use or effectiveness. This inconsistency can lead to potential misuse or complications during treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face potential health risks due to misleading labeling. Immediate action is necessary to avoid adverse health effects.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device against the recalled models.
- Look for the UDI associated with your model to confirm if it is affected.
- Consult your healthcare provider for assistance if unsure.
Where to find product info
You can typically find the model number and UDI on the device packaging or directly on the device itself.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements once initiated with the manufacturer.
If the manufacturer is unresponsive
- Contact Orthofix again through multiple channels if there is no response.
- Document all communications for your records.
- Consider reaching out to regulatory bodies if necessary.
How to prevent similar issues
- Always verify labeling and claims of medical devices before purchase.
- Stay informed about recalls and safety alerts for medical devices.
- Consult healthcare professionals for recommendations on safe alternatives.
Documentation advice
Keep all correspondence related to the recall and any documents proving purchase or communication with the manufacturer.
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Product Details
The recalled models include 39-9012SP, 39-9014SP, 39-9016SP, 39-9018SP, 39-9212SP, 39-9214SP, 39-9216SP, 39-9218SP, 39-2012SP, 39-2014SP, 39-2016SP, 39-2018SP, 39-2212SP, 39-2214SP, 39-2216SP, 39-2218SP. These devices were distributed worldwide, including states such as CA, TX, and NY. No specific price was provided.
Key Facts
- Recall date: November 3, 2025
- Distributed worldwide including the U.S. and countries like AU, DE, and GB
- Class III recall due to labeling issues
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Safety Guide
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