Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brand
- XTANT Medical Holdings
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- XTANT Medical Holdings
- Product type
- Pedicle Screw System
- Model numbers
- UDI/DI M697X0736555DL1, Lot Number 4375-01
- Sizes
- 6.5 x 50 mm
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 18, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact XTANT Medical Holdings, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
Pedicle screws are used in spinal fusion surgeries to anchor implants to vertebrae. The Xpress Dual Lead 6.5 x 50 mm is a specific length used in certain procedures.
Why This Is Dangerous
Mislabeled length could lead to selection of the wrong screw during surgery, potentially impacting fixation. Exact risk is determined by surgical context.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate usage halt to protect patients; providers must verify labeling before any procedure and coordinate with XTANT for next steps.
Practical Guidance
How to identify if yours is affected
- Check part number X073-6555-DL.
- Verify UDI M697X0736555DL1.
- Confirm Lot Number 4375-01.
Where to find product info
UDI label on device packaging; lot sticker on container; hospital records
What timeline to expect
Coordinate with manufacturer for replacement; recall processing details to follow
If the manufacturer is unresponsive
- Escalate to hospital procurement, contact FDA via recall portal, consider legal counsel if delays occur.
- Document all correspondence and timeline for patient records.
How to prevent similar issues
- Implement strict labeling verification for surgical hardware.
- Audit third-party suppliers and distributions for correct labeling.
- Maintain updated recall watchlists for implants.
- Ensure staff training on recognizing mislabeled devices.
Documentation advice
Keep recall letter, serials, lot numbers, and replacement instructions; document patient impact and outcomes.
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Product Details
Brand: XTANT Medical Holdings. Product: Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm. Part Number: X073-6555-DL. UDI/DI: M697X0736555DL1. Lot Number: 4375-01. Units recalled: 2. Distribution: United States, Oregon (OR). Recall date: 2026-02-18. Status: Active.
Reported Incidents
0 injuries or incidents reported in the provided data.
Key Facts
- UDI/DI M697X0736555DL1
- Distributed in OR, US
- High hazard level
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