Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (4Level, 76mm) due to locking mechanism disassociating during surgery or after. 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 (4Level, 76mm) because the locking mechanism can become detached during surgery or after the procedure. This could require additional surgery or revision to fix the issue.
The locking mechanism in the CervAlign plate system can become detached either during surgery or after the procedure. This detachment may require additional surgery or revision to correct the issue.
Patients who received the CervAlign Anterior Cervical Plate System (4Level, 76mm) with specific batch numbers during spinal surgery are affected. Surgeons and medical staff who used these products are most at risk.
Check for the product name 'CervAlign Anterior Cervical Plate System (4Level, 76mm)' with Material Number 66-476. Affected units include batch numbers 342456, 348031, 351954, 357128, 364540, 370414, 381213, 381525, and 383204.
Reach out to your surgeon to determine if you received the affected batch numbers of the CervAlign Anterior Cervical Plate System.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, potentially requiring additional surgery or revision.
Batch numbers 342456, 348031, 351954, 357128, 364540, 370414, 381213, 381525, and 383204.
No, the recall does not require immediate discontinuation. Patients should contact their surgeon to determine if they received affected units.
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-1232-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1232-2021 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.
