Centinel Spine recalls Prodisc C SK cervical disc replacements with possible blue discoloration indicating foreign contamination. Affected units have model PDSM5 and lot 2024-0482. No remedy specified in official notice.
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 have blue discoloration during assembly. This could indicate foreign contamination that wasn't fully evaluated in manufacturing, potentially affecting safety.
During manufacturing, some Prodisc C SK discs showed blue discoloration, which may be a foreign contaminant. This contamination wasn't fully checked during quality control, so it could pose an unknown safety risk during implantation.
Patients who received Prodisc C SK cervical disc replacements with model PDSM5 and lot 2024-0482 are affected. Surgeons and medical facilities using this specific model are most at risk.
Check for model number PDSM5 and lot number 2024-0482 on the device. The product is a cervical disc replacement used in spinal surgery.
Look for model number PDSM5 and lot number 2024-0482 on the Prodisc C SK device.
The official recall notice does not specify any remedy.
The recall notice does not provide specific action steps for affected users.
Check for model number PDSM5 and lot number 2024-0482 on the device.
We’ve drafted a message you can send Centinel Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-3212-2024 — Centinel Spine Centinel Spine Hello, I own a Centinel Spine that is covered by recall Z-3212-2024 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.
