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 |
| Recall / campaign no. | Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776; |
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.
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.