Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (5-level) with material number 66-580 due to locking mechanism disassociating during surgery or after. Affected units include batch numbers 345223, 352338, 35711:19, 372239, 382116.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical is recalling a specific type of cervical plate system used in spinal surgery because its locking mechanism can become loose during or after surgery. This could require additional surgery to fix the problem, which is why it matters for patients who have had or are scheduled for this procedure.
The locking mechanism in the CervAlign plate system can become loose either during surgery or after the procedure. This may require additional surgery to replace or revise the device, which poses a risk of complications for patients.
Patients who have had or are scheduled for spinal surgery using this specific CervAlign plate system are most at risk. The recall affects patients with certain spinal conditions like degenerative disc disease, trauma, or spinal stenosis.
Check for the product name 'CervAlign Anterior Cervical Plate System' with 5 levels and 80mm size. The material number is 66-580. Affected units have batch numbers 345223, 352338, 357119, 372239, or 382116.
Identify the material number (66-580) and batch numbers (345223, 352338, 357119, 372239, 382116) to confirm if your device is affected.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, which may require additional surgery to replace or revise the device.
Check the material number and batch numbers to see if your device is affected. If it is, contact Pioneer Surgical for guidance.
The product is safe for use in most cases, but the recall indicates a risk of the locking mechanism becoming loose during or after surgery, which may require additional procedures.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1239-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1239-2021 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.
