Quick Facts at a Glance
- Recall Date
- June 24, 2025
- Hazard Level
- HIGH
- Brand
- Orthofix U.S.
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Intervertebral body fusion device
- Model numbers
- UDI-DI: 18257200161010, Lot 001, Lot 002, Lot 003
- Sizes
- 37mm W x 28mm D x 18mm H
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 24, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
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: Letter
About This Product
Pillar SA Ti is a sterile spinal interbody fusion device used in fusion surgeries. It measures 37 mm wide, 28 mm deep, and 18 mm tall with a 20-degree angle labeled on the device.
Why This Is Dangerous
A labeling discrepancy could lead to misinterpretation of device width. The front label shows 37 mm while side labels state 33 mm, which could influence surgical sizing decisions.
Industry Context
This recall is not described as part of a broader industry pattern in the available information.
Real-World Impact
The recall may cause procedure delays and necessitate device exchanges if incorrect size labeling occurred.
Practical Guidance
How to identify if yours is affected
- Verify the device width by comparing front label 37 mm to side flap label 33 mm
- Check REF 82-3713SP and UDI-DI 18257200161010
- Note Lot numbers 001, 002, 003
- Confirm sterile packaging and labeling before use
- If in doubt, contact the hospital's purchasing or Orthofix U.S. LLC
Where to find product info
Labels on device packaging and outer side flap; UDI-DI on the packaging
What timeline to expect
Refund or replacement timelines are not specified; typical recalls process may take 4-8 weeks
If the manufacturer is unresponsive
- Document all contact attempts
- File a complaint with the FDA if the company is unresponsive
- Coordinate with the hospital risk management office
How to prevent similar issues
- Verify labeling during purchasing and prior to procedures
- Use certified distributors and verify recall status before implanting
- Keep a copy of recall letters for medical records
Documentation advice
Keep the recall notice, packaging, device labels, serial numbers, and hospital correspondence
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Product Details
Model numbers and lot codes: UDI-DI 18257200161010. Lots 001, 002, 003. Device: Pillar SA Ti, sterile, 37 mm W x 28 mm D x 18 mm H, 20-degrees. REF: 82-3713SP. Distribution: US nationwide in CO and CA. Quantity: 3.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 37 mm width confirmed on front label
- Label discrepancy involves outer side flap and inner label box
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Safety Guide
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