Recall Z-1426-2026— Centinel Spine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Centinel Spine, Inc., initiated 2025-12-31. FDA's recall record names no specific 510(k) clearance for this event. 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: Products were mislabeled as the 6mm product but included the 5 mm product..
- Recalling firm
- Centinel Spine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-31
- Firm location
- West Chester, PA, United States
Product description
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 for recall
Products were mislabeled as the 6mm product but included the 5 mm product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.