Centinel Prodisc C SK U.S. Implant Extra Large 5mm - Labeling Mixup Recall
Centinel Spine recalls Prodisc C SK U.S. Implant Extra Large 5mm (Model PDSXL5) due to labeling error where 5mm and 6mm products were swapped. No action needed as it's a labeling issue, not a safety hazard.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large 5mm (Model PDSXL5) because the product was mislabeled as 5mm when it's actually 6mm and vice versa. This labeling mix-up doesn't pose a safety risk, so no action is required. Read more at govinfonow.com/recall/49652-centinel-prodisc-c-sk-u-s-implant-extra-large-5mm.
Source Summary by GovInfoNow · govinfonow.com/recall/49652-centinel-prodisc-c-sk-u-s-implant-extra-large-5mm · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2050-2026
Cite this page
“Centinel Prodisc C SK U.S. Implant Extra Large 5mm - Labeling Mixup Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49652-centinel-prodisc-c-sk-u-s-implant-extra-large-5mm. Based on FDA recall #Z-2050-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2050-2026%22&limit=1).
Why it’s dangerous
The product was mislabeled, meaning the 5mm implant was labeled as 6mm and the 6mm implant was labeled as 5mm. This could lead to confusion during surgical procedures but does not cause injury or malfunction in normal use.
Who’s affected
Patients who received the Prodisc C SK U.S. Implant Extra Large 5mm (Model PDSXL5) during spinal surgery are likely affected. Surgeons and medical staff who used the product are at risk of confusion during procedures.
How to tell if you have this one
Check if your implant is labeled as 'Prodisc C SK U.S. Implant Extra Large 5mm' with model number PDSXL5. The lot number is 2026-0026 and UDI-DI is 00843193113979.
- Brand
Centinel Spine- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
| Recall number | Product, codes & lots |
|---|---|
| Z-2050-2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.; Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026 |
| Z-2051-2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.; Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027 |
What to do — step by step
Check Product Label
Look for the model number PDSXL5 and lot number 2026-0026 on the implant packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee, Texas.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2050-2026 (March 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2050-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.