Centinel Spine recalls Prodisc C SK cervical disc replacements with potential foreign contaminant. Affected units may have blue discoloration from manufacturing. Contact for remedy details.
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Centinel Spine is recalling Prodisc C SK cervical disc replacements that may contain a foreign contaminant causing blue discoloration. This could pose a risk if the contaminant affects the disc's safety during surgery.
During manufacturing, a blue discoloration was observed on some Prodisc C inlays. This discoloration is considered a foreign contaminant that may not have been fully evaluated in quality checks. If the contaminant affects the disc's integrity during surgery, it could lead to complications.
Patients who received Prodisc C SK cervical disc replacements with model number PDSM5 and lot code UDI-DI 00843193113856 are affected. Surgeons and medical staff who used these specific units during procedures are most at risk.
Check for model number PDSM5 and lot code UDI-DI 00843193113856 on the product packaging. The product was sold in 2024 with lot number 2024-0482.
Verify the model number PDSM5 and lot code UDI-DI 00843193113856 on the product packaging.
The recall indicates a potential foreign contaminant that may not have been fully evaluated during manufacturing, but no specific injury reports were mentioned.
The recall record does not specify a remedy, so contact Centinel Spine directly for guidance.
Check for model number PDSM5 and lot code UDI-DI 00843193113856 on the product packaging.
We’ve drafted a message you can send Centinel Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-3213-2024 — Centinel Spine Centinel Spine Hello, I own a Centinel Spine that is covered by recall Z-3213-2024 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.
