🔍 RecallPedia

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Class I - Dangerous
🏥 Medical Devices Recalled: March 20, 2026 Centinel Spine Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Centinel Spine, Inc.
Reason for Recall:
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Product Codes/Lot Numbers:

Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2051-2026

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