Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (4Level, 64mm) due to locking mechanism disassociating during or after surgery. Affected units have specific batch numbers.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical is recalling their CervAlign Anterior Cervical Plate System (4Level, 64mm) because the locking mechanism can become detached during or after surgery. This could lead to needing additional surgery 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 to replace or fix the device.
Surgical patients who received the CervAlign Anterior Cervical Plate System (4Level, 64mm) with specific batch numbers. Patients who had surgery for neck conditions like degenerative disc disease or spinal stenosis are most at risk.
Check if your CervAlign Anterior Cervical Plate System (4Level, 64mm) has batch numbers 342453, 348028, 351951, 357126, 364538, 370411, or 380157. This product is used for neck surgeries to treat conditions like degenerative disc disease or spinal stenosis.
Your surgeon can confirm if your CervAlign plate system has the affected batch numbers and advise next steps.
The locking mechanism has been observed to disassociate either during or after surgery, which may require additional surgery to replace or fix the device.
Batch numbers 342453, 348028, 351951, 357126, 364538, 370411, and 380157.
No, but your surgeon should check if your device has the affected batch numbers and may recommend additional surgery if needed.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1229-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1229-2021 from Pioneer Surgical. 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.
