Reported May 13, 2026 · Ongoing
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Centinel Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Centinel Spine, Inc. · 900 Airport Rd Ste 3b · West Chester, PA · 19380-3416
Is this the product you have?
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM
- ModelPDSXL5 Total cervical disc replacement
- Lot codes and dates
- Model NumberPDSXL5
- UDI-DI00843193113979
- Lot Number2026-0026
- Amount recalled
- 30 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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