Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (2Level, 42mm) with material number 66-242 due to locking mechanism disassociation risk during surgery or after implantation. Affected units include specific batch numbers.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology is recalling their CervAlign Anterior Cervical Plate System (2Level, 42mm) because the locking mechanism can become loose during surgery or after implantation, potentially requiring replacement or revision surgery. This recall affects patients who have received this specific spinal implant.
The locking mechanism in this spinal implant can become disassociated either during surgery or after the implant is placed. This means the device may not stay securely in place, potentially requiring additional surgery to replace or revise the implant.
Patients who received the CervAlign Anterior Cervical Plate System (2Level, 42mm) with material number 66-242 and specific batch numbers are affected. Those who have undergone spinal surgery for conditions like degenerative disc disease or spinal stenosis are most at risk.
Check for the product name 'CervAlign Anterior Cervical Plate System (2Level, 42mm)' with material number 66-242. Affected units include batch numbers 332506, 338836, 342573, 344105, 350523, 361814, 364756, 366089, 369339, and 379083.
Identify the material number and batch numbers to confirm if your device is affected.
Reach out to Pioneer Surgical Technology for guidance on next steps if your device is affected.
The locking mechanism in the CervAlign Anterior Cervical Plate System can become disassociated during surgery or after implantation, potentially requiring replacement or revision surgery.
Affected batch numbers are 332506, 338836, 342573, 344105, 350523, 361814, 364756, 366089, 369339, and 379083.
No immediate stop is required, but affected patients should contact Pioneer Surgical Technology for guidance on whether replacement or revision surgery is needed.
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-1219-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1219-2021 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.
