Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (1 Level, 16mm) with Material Number 66-116 due to locking mechanism disassociating during surgery or after. Affected units include batch numbers 328898 and 328899.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology recalls a specific type of cervical plate system for spinal surgery. The locking mechanism may become loose during or after surgery, requiring replacement or revision. This poses a risk of needing additional surgery to fix the issue.
The locking mechanism in this spinal plate system can become loose during surgery or after the procedure. This may require additional surgery to replace or revise the device, increasing the risk of complications.
Surgical patients who received the CervAlign Anterior Cervical Plate System (1 Level, 16mm) with Material Number 66-116 and batch numbers 328898 or 328899. Surgeons and medical staff using this product are most at risk.
Check for the product name 'CervAlign Anterior Cervical Plate System', model '1 Level, 16mm', and Material Number 66-116. Affected units were manufactured with batch numbers 328898 or 328899.
Identify the Material Number and batch numbers to confirm if your device is affected.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, potentially requiring replacement or revision.
Check the Material Number and batch numbers to see if your device is affected. If it is, contact Pioneer Surgical Technology for further instructions.
The recall indicates the locking mechanism may become loose, requiring additional surgery. This could lead to complications, but the record 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-1207-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1207-2021 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.
