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.
Reason for Recall / Hazard
Products were mislabeled as the 6mm product but included the 5 mm product.
Product Description & Identification
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Affected Products
Brand 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 |
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Overview
- Recalling FirmCentinel Spine, Inc.
- StatusOngoing
- Risk LevelClass 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/recalls/brand-name-prodisc-product-name-prodisc-c-sk-model-catalog-number-pdsl/FDA-Z-1426-2026
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