[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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