Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (4Level, 72mm) with material number 66-472 due to locking mechanism disassociating during surgery or after. Affected batches include 342455, 348030, 351953, 356880, 359851, 380679, 380680, 385418.
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, 72mm) with material number 66-472 because the locking mechanism can become detached during surgery or after the procedure. This could lead to the need for additional surgery or revision.
The locking mechanism in this spinal plate system can become detached either during surgery or after the procedure. This disassociation may require the patient to undergo additional surgery or revision to correct the issue.
Patients who have undergone spinal surgery using this specific plate system are most at risk. The recall affects patients who received the CervAlign Anterior Cervical Plate System (4Level, 72mm) with material number 66-472.
Check for the product name 'CervAlign Anterior Cervical Plate System (4Level, 72mm)' with material number 66-472. Affected batches include 342455, 348030, 351953, 356880, 359851, 380679, 380680, and 385418.
Identify the material number and batch numbers listed in the recall notice to confirm if your device is affected.
The locking mechanism has been observed to disassociate either intraoperatively or postoperatively, which may require replacement or revision surgery.
Check the material number and batch numbers listed in the recall notice to see if your device is affected. If it is, contact Pioneer Surgical for further instructions.
Batches 342455, 348030, 351953, 356880, 359851, 380679, 380680, and 385418 are affected.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1231-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1231-2021 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.
