Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (4Level, 88mm) with material number 66-488 due to locking mechanism disassociating during surgery or after. Affected batch numbers include 342459, 348034, 351957, 357131, 364771, 381524, 385440.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology recalls a specific cervical plate system (CervAlign 4Level, 88mm) because its locking mechanism can become detached during surgery or after surgery. This could require additional surgery or revision to fix the issue.
The locking mechanism in this cervical plate system can become detached either during surgery or after the procedure. This detachment may require additional surgery or revision to correct the issue, potentially leading to complications.
Surgical patients who received this specific cervical plate system during procedures between the listed batch numbers. Surgeons and medical facilities using the product are most at risk of needing additional surgery.
Check if your cervical plate has the model name 'CervAlign 4Level, 88mm' and material number 66-488. Affected batches include 342459, 348034, 351957, 357131, 364771, 381524, and 385440.
Verify your cervical plate's model name, material number, and batch number against the listed specifications.
The locking mechanism has been observed to disassociate either during surgery or after surgery, which may require replacement or revision surgery.
Check your product's model name, material number, and batch number. If it matches the recalled specifications, contact Pioneer Surgical Technology for further instructions.
Yes, the locking mechanism disassociating could require additional surgery or revision, potentially leading to complications.
We’ve drafted a message you can send Pioneer Surgical Technology to request your refund or repair — edit it as you like.
Subject: Recall Z-1235-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1235-2021 from Pioneer Surgical Technology. 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.
