Cervical Disc Recall: Centinel Prodisc PDSXL5 5MM
Announced 2026-05-13 · FDA
Twenty units of Centinel Spine Prodisc C SK total cervical disc replacement were mislabeled as 6 mm but actually included the 5 mm product. The devices were distributed nationwide in AL, CA, CO, LA, NY, OR, TN, TX. The recall is FDA-issued and lists Model PDSL6 with UDI-DI 00843193113924 and Lot 2025-0776.
| Brand | Centinel Spine, Inc. |
|---|---|
| Product | Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No |
| Reason | Products were mislabeled as the 6mm product but included the 5 mm product. |
| Severity | moderate |
| Units affected | 30 |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Contact your surgeon or implanting facility to determine if your device is affected and what steps to take.
- Do not attempt to modify or remove the implanted device yourself; follow your surgeon's guidance.
- If advised, coordinate with the manufacturer or hospital for replacement, monitoring, or further evaluation and report any related symptoms to your clinician.
- Keep recall details (Model PDSL6, UDI 00843193113924, Lot 2025-0776) handy when discussing with health professionals.
How to identify the recalled item
| Lot / date codes | Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776; |
|---|---|
| Lot / date codes | Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.