FDA Medical devices recall ·
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical… recall
- Recall number
- Z-2050-2026
- Date
- (initiated March 20, 2026)
- 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
- 30 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Why was it recalled?
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
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: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
Distribution
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
States: Arizona California Georgia Louisiana Missouri New York 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-2050-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.