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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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.

The Hazard

The Prodisc C SK was mislabeled, which may lead to improper surgical procedures. Using the incorrect size could result in serious complications during or after surgery.

Reported Incidents

No specific incidents have been reported. However, the potential for serious injury exists if patients receive the incorrect device.

What to Do

Patients and healthcare providers should stop using this device immediately. Contact Centinel Spine, Inc. or your healthcare provider for further instructions.

Contact Information

For more information, visit the Centinel Spine website or call your healthcare provider. Additional details are available on the FDA recall page.

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

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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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