Centinel Spine recalls Prodisc C SK U.S. Implant Extra Large 5mm (Model PDSXL5) due to labeling error where 5mm and 6mm products were swapped. No action needed as it's a labeling issue, not a safety hazard.
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.
Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large 5mm (Model PDSXL5) because the product was mislabeled as 5mm when it's actually 6mm and vice versa. This labeling mix-up doesn't pose a safety risk, so no action is required.
The product was mislabeled, meaning the 5mm implant was labeled as 6mm and the 6mm implant was labeled as 5mm. This could lead to confusion during surgical procedures but does not cause injury or malfunction in normal use.
Patients who received the Prodisc C SK U.S. Implant Extra Large 5mm (Model PDSXL5) during spinal surgery are likely affected. Surgeons and medical staff who used the product are at risk of confusion during procedures.
Check if your implant is labeled as 'Prodisc C SK U.S. Implant Extra Large 5mm' with model number PDSXL5. The lot number is 2026-0026 and UDI-DI is 00843193113979.
Look for the model number PDSXL5 and lot number 2026-0026 on the implant packaging.
No, this is a labeling mix-up that does not pose a safety risk. The product is safe to use as it's a mislabeling issue, not a hazard.
No action is required. This recall is for labeling clarification only, not a safety hazard.
The model number is PDSXL5 for the Prodisc C SK U.S. Implant Extra Large 5mm.
We’ve drafted a message you can send Centinel Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-2050-2026 — Centinel Spine Centinel Spine Hello, I own a Centinel Spine that is covered by recall Z-2050-2026 from Centinel Spine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
