Quick Facts at a Glance
- Recall Date
- March 20, 2026
- Hazard Level
- HIGH
- Brand
- Centinel Spine
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Centinel Spine
- Model numbers
- Model Number: PDSXL5, UDI-DI: 00843193113979, Lot Number: 2026-0026
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 20, 2026
Reported by FDA DEVICE
May 13, 2026
RecallRadar source check
May 20, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Centinel Spine, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Full Description
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.. Reason: 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.. Classification: Class II. Quantity: 30 units. Distribution: US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
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Safety Guide
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Read: How to Get Refunds and ReplacementsWant to Know First?
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