Centinel Spine recalls Prodisc C SK U:6mm cervical disc implants due to labeling mix-up between 5mm and 6mm models. No action needed as the error doesn't affect safety.
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 6mm cervical disc replacements because they were mislabeled as 5mm instead of 6mm. This labeling error doesn't pose a safety risk to users.
The product was mislabeled: the 6mm implant was labeled as 5mm and the 5mm implant was labeled as 6mm. This labeling error does not cause physical harm or safety issues during use.
Patients who received the Prodisc C SK U.S. Implant Extra Large 6mm (model PDSXL6) cervical disc replacement are likely affected. The risk is minimal as the mislabeling does not impact safety.
Check if your cervical disc replacement is labeled as 'Prodisc C SK U.S. Implant Extra Large 6mm' with model number PDSXL6. The product was sold in the U.S. with lot number 2026-0027.
Verify the model number on your cervical disc replacement; it should be PDSXL6 for the Extra Large 6mm version.
No, the labeling mix-up does not pose a safety risk. The product is safe to use as the error does not affect function.
No action is required. The mislabeling does not impact safety, so the product can be used normally.
The model number for the affected product is PDSXL6 (Prodisc C SK U.S. Implant Extra Large 6mm).
We’ve drafted a message you can send Centinel Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-2051-2026 — Centinel Spine Centinel Spine Hello, I own a Centinel Spine that is covered by recall Z-2051-2026 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.
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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.
