FDAHealthDecember 31, 2025
Centinel Spine, Inc. — Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
⚠️ Products were mislabeled as the 6mm product but included the 5 mm product.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 31, 2025
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
What's affected?
- Product
- Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
- Brand
- Centinel Spine, Inc.
- Lot code
- 2025-0776
Additional details
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20 units.
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