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: 38-1007SP 18257200091577 38-1008SP 18257200091584 38-1009SP 18257200091591 38-1010SP 18257200111404 38-1011SP 18257200091614 38-1012SP 18257200091621 38-1013SP 18257200091638 38-1014SP 18257200091645 38-1707SP 18257200092185 38-1708SP 18257200092192 38-1709SP 18257200092208 38-1710SP 18257200092215 38-1711SP 18257200092222 38-1712SP 18257200092239 38-1713SP 18257200092246 38-1714SP 18257200092253 38-1807SP 18257200092024 38-1808SP 18257200092031 38-1809SP 18257200092048 38-1810SP 18257200092055 38-1811SP 18257200092062 38-1812SP 18257200092079 38-1813SP 18257200111305 38-1814SP 18257200092093 38-3007SP 18257200091881 38-3008SP 18257200091898 38-3009SP 18257200091904 38-3010SP 18257200091911 38-3011SP 18257200091928 38-3012SP 18257200091935 38-3013SP 18257200091942 38-3014SP 18257200091959 38-4007SP 18257200091720 38-4008SP 18257200091737 38-4009SP 18257200091744 38-4010SP 18257200091751 38-4011SP 18257200111411 38-4012SP 18257200091775 Part Number GTIN 38-4013SP 18257200091782 38-4014SP 18257200091799 38-4207SP 18257200092109 38-4208SP 18257200092116 38-4209SP 18257200092123 38-4210SP 18257200092130 38-4211SP 18257200092147 38-4212SP 18257200092154 38-4213SP 18257200092161 38-4214SP 18257200092178 38-4508SP 18257200092260 38-4509SP 18257200092277 38-4510SP 18257200092284 38-4511SP 18257200092291 38-4512SP 18257200092307 38-4513SP 18257200092314 38-4514SP 18257200092321 38-6007SP 18257200091805 38-6008SP 18257200091812 38-6009SP 18257200091829 38-6010SP 18257200091836 38-6011SP 18257200091843 38-6012SP 18257200091850 38-6013SP 18257200091867 38-6014SP 18257200091874 38-7008SP 18257200091652 38-7009SP 18257200091669 38-7010SP 18257200091676 38-7011SP 18257200091683 38-7012SP 18257200091690 38-7013SP 18257200091706 38-7014SP 18257200091713 38-9009SP 18257200091966 38-9010SP 18257200091973 38-9011SP 18257200091980 38-9012SP 18257200091997 38-9013SP 18257200092000 38-9014SP 18257200092017
- 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 FORZA PTC Spacer System is a medical device used in various healthcare applications. Consumers purchase this product for its intended purpose in orthopedic treatments and rehabilitation.
Why This Is Dangerous
The device's labeling contains claims that are not consistently present, which can mislead consumers and healthcare providers about its safety and effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product immediately to avoid potential health risks. The recall may cause inconvenience for users needing replacements or alternative therapies.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recall list.
- Look for the product packaging for additional identifiers.
- Verify purchase records for the recalled product.
Where to find product info
Model numbers can typically be found on the packaging or on the device itself near the labeling.
What timeline to expect
Expect 4-6 weeks for refund processing after initiating the recall process.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Contact consumer protection agencies if no response is received.
- Consider reaching out to healthcare providers for assistance.
How to prevent similar issues
- Always verify product claims and certifications before purchase.
- Check for recent recalls on medical devices regularly.
- Purchase medical devices only from reputable retailers.
Documentation advice
Keep all receipts, correspondence, and photos related to the recall for your records.
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Product Details
The recalled models include 38-1007SP through 38-9014SP. The products were distributed worldwide, including in all U.S. states and various countries such as Canada and Germany. The devices range in dimensions, with various widths and heights.
Key Facts
- Recall date: November 3, 2025
- Quantity recalled: 34,582 units
- Labeling claims inconsistent
- No injuries reported
- Contact Orthofix for instructions
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Safety Guide
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