Quick Facts at a Glance
- Recall Date
- December 31, 2025
- Hazard Level
- HIGH
- Brand
- Centinel Spine
- 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
- Centinel Spine
- Product type
- Cervical Disc Replacement
- Model numbers
- Model Number: PDSL6, UDI-DI 00843193113924, Lot 2025-0776
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 31, 2025
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Products were mislabeled as the 6mm product but included the 5 mm product.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Centinel Spine, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Prodisc C SK is a total cervical disc replacement device used in spinal surgeries to alleviate pain and restore functionality. Consumers typically buy this device for surgical procedures involving cervical spine issues.
Why This Is Dangerous
The mislabeling of the product may lead to the use of an incorrect size during surgery, potentially resulting in surgical complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers face potential health risks if they have received the incorrect device during surgery, necessitating immediate action to avoid complications.
Practical Guidance
How to identify if yours is affected
- Verify the model number is PDSL6 on your device.
- Check for the lot number 2025-0776 to confirm the recall.
- Contact your healthcare provider to confirm if your device is affected.
Where to find product info
Model numbers can typically be found on the packaging or patient information leaflet that came with the device.
What timeline to expect
Expect processing for refunds or replacements to take 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Follow up with Centinel Spine via phone or email.
- File a complaint with the FDA if no response is received.
How to prevent similar issues
- Always verify the specifications of medical devices before surgery.
- Consult with healthcare providers about the latest updates on recalls.
Documentation advice
Keep all communications regarding the recall, including emails and letters from Centinel Spine or healthcare providers.
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Product Details
The recalled product is the Prodisc C SK, model number PDSL6. It was distributed nationwide in states such as Alabama, California, and Texas. The quantity recalled is 20 units.
Key Facts
- Mislabeled as 6mm but included 5mm
- High hazard level
- Affected states: AL, CA, CO, LA, NY, OR, TN, TX
- Contact Centinel Spine for instructions
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Safety Guide
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