Centinel Spine, Inc.: Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical dis
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Centinel Spine, Inc.
- 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
- Reason / hazard
- Products were mislabeled as the 6mm product but included the 5 mm product.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
- Recall initiated
- 2025-12-31
- Code info
- Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
- Product quantity
- 20 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- West Chester
- State
- PA
- Country
- United States
- Event id
- 98282
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