Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
USBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Recalling Firm: Centinel Spine, Inc.
Motivo del Retiro / Peligro
TranslatedProducts were mislabeled as the 6mm product but included the 5 mm product.
Descripción del Producto e Identificación
TranslatedBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Productos Afectados
TranslatedBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Additional Source Details
| Field | Value |
|---|---|
| City | West Chester |
| State | PA |
| Event id | 98282 |
| Address 1 | 900 Airport Rd Ste 3b |
| Code info | Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776; |
| Postal code | 19380-3416 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 20 units |
| Reason for recall | Products were mislabeled as the 6mm product but included the 5 mm product. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251231 |
| Initial firm notification | Letter |
| Center classification date | 20260217 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description:...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableCentinel Spine, Inc.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUS Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
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🚨 SAFETY ALERT: Centinel Spine, Inc. - Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No Check if your household is affected: https://therecallfile.com/es/recalls/brand-name-prodisc-product-name-prodisc-c-sk-model-catalog-number-pdsl/FDA-Z-1426-2026
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