Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A
Pending LLM rewrite. Source: FDA_DEVICE Z-1426-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Products were mislabeled as the 6mm product but included the 5 mm product.
The recalled product
- 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
- Manufacturer
- Centinel Spine, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: PDSL6
- UDI-DI 00843193113924
- Lot 2025-0776
Distribution
Distributed nationwide across the United States.
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