Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (1 Level, 10mm) due to locking mechanism disassociating during or after surgery, potentially requiring revision. Affected units include specific batch numbers.
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 (1 Level, 10mm) because the locking mechanism may become loose during or after surgery, requiring replacement. This could lead to additional surgery if the device becomes unstable.
The locking mechanism in the CervAlign plate system can become loose during surgery or after surgery. If it becomes loose, the device may need to be replaced or revised, which could require additional surgery.
Surgical patients who received the CervAlign Anterior Cervical Plate System (1 Level, 10mm) with batch numbers 328891 or 328892 are affected. Patients who have had 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 (1 Level, 10mm)' with material number 66-110. Affected units have batch numbers 328891 or 328892.
Identify the material number (66-110) and batch numbers (328891 or 328892) on your CervAlign Anterior Cervical Plate System.
The locking mechanism has been observed to disassociate either during or after surgery, potentially requiring replacement or revision.
Check the material number and batch numbers on your device. If it matches the recalled units (material number 66-110, batch numbers 328891 or 328892), contact Pioneer Surgical Technology for guidance.
The recall states that disassociation may require additional surgery, but the official notice does not specify a risk of serious injury in normal use.
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-1204-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1204-2021 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.
