Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (4Level, 68mm) with material number 66-468 due to locking mechanism disassociating during surgery or after. Affected batches include 342454, 348029, 351952, 357127, 364539, 370412, 380678.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology recalls their CervAlign Anterior Cervical Plate System (4Level, 68mm) with material number 66-468 because the locking mechanism may disassociate during surgery or after surgery, requiring replacement or revision. This could lead to complications if the plate becomes unstable after implantation.
The locking mechanism in the CervAlign plate system may become loose during surgery or after the procedure, causing the plate to become unstable. This instability could lead to the need for additional surgery to replace or revise the implant.
Surgical patients who received the CervAlign Anterior Cervical Plate System (4Level, 68mm) with material number 66-468 during procedures between the specified batch dates are affected. Patients who have had spinal surgery for conditions like degenerative disc disease, spinal stenosis, or trauma are most at risk.
Check if your CervAlign Anterior Cervical Plate System is labeled with material number 66-468 and batch numbers 342454, 348029, 351952, 357127, 364539, 370412, or 380678. The product is intended for anterior cervical fixation (C2-C7) for conditions like degenerative disc disease, spinal stenosis, or trauma.
Identify if your CervAlign Anterior Cervical Plate System has material number 66-468 and the listed batch numbers.
The locking mechanism may disassociate either during surgery or after surgery, requiring replacement or revision.
The recall record does not specify a remedy, so contact Pioneer Surgical Technology directly for guidance.
Batch numbers 342454, 348029, 351952, 357127, 364539, 370412, and 380678 are affected.
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-1230-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1230-2021 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.
