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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Centinel Spine Prodisc C SK Cervical Discs Recalled for Labeling Mix-Up

Agency Publication Date: May 1, 2026
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Summary

Centinel Spine, Inc. is recalling 30 units of its Prodisc C SK Total Cervical Disc Replacement implants due to a labeling error. The 6mm extra-large implants were mistakenly labeled as 5mm, while the 5mm extra-large implants were labeled as 6mm. This mix-up could lead to a surgeon selecting and attempting to implant the wrong size disc during surgery.

Risk

Using an incorrectly sized spinal disc implant can result in surgical delays, improper fit within the spine, or the need for additional medical procedures to correct the placement of the device.

What You Should Do

  1. Identify if you have the affected implants by checking the model and lot numbers on the product packaging.
  2. For the Prodisc C SK Extra Large 5mm product, look for Model Number PDSXL5 and Lot Number 2026-0026.
  3. For the Prodisc C SK Extra Large 6mm product, look for Model Number PDSXL6 and Lot Number 2026-0027.
  4. Stop using the recalled device immediately.
  5. Contact Centinel Spine, Inc. or your distributor to arrange for the return, replacement, or correction of the mislabeled units.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM
Variants: Extra Large, 5mm
Model / REF:
PDSXL5
Lot Numbers:
2026-0026
UDI:
00843193113979

Total cervical disc replacement.

Product: Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM
Variants: Extra Large, 6mm
Model / REF:
PDSXL6
Lot Numbers:
2026-0027
UDI:
00843193113986

Total cervical disc replacement.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98721
Status: Active
Manufacturer: Centinel Spine, Inc.
Sold By: Authorized medical distributors; Direct to hospitals
Manufactured In: United States
Units Affected: 30
Distributed To: Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.