FDA Medical devices recall ·
Prodisc Product Name: Prodisc C SK Model recall
- Recall number
- Z-1426-2026
- Date
- (initiated December 31, 2025)
- Company / brand
- Centinel Spine, Inc.
900 Airport Rd Ste 3b, West Chester, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Products were mislabeled as the 6mm product but included the 5 mm product.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
Distribution
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
States: Alabama California Colorado Louisiana New York Oregon Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1426-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.