HIGH

Centinel Spine Recalls Prodisc C SK Cervical Disc Over Mislabeled Product

Centinel Spine recalled 20 units of the Prodisc C SK cervical disc on December 31, 2025. The products were mislabeled as the 6mm variant but included the 5mm variant. The recall affects patients in multiple states including California and New York.

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

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

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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

  1. Verify the model number is PDSL6 on your device.
  2. Check for the lot number 2025-0776 to confirm the recall.
  3. 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.

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

  • 20 units recalled
  • Mislabeled as 6mm but included 5mm
  • High hazard level
  • Affected states: AL, CA, CO, LA, NY, OR, TN, TX
  • Contact Centinel Spine for instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCervical Disc Replacement
Sold At
Multiple Retailers

Product Details

Model Numbers
Model Number: PDSL6
UDI-DI 00843193113924
Lot 2025-0776
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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