Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (4Level, 80mm) due to locking mechanism disassociating during or after surgery, potentially requiring replacement.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical is recalling a specific cervical plate system used in spine surgery because its locking mechanism may become loose during or after surgery, requiring replacement. This could lead to the need for additional surgery if the plate becomes unstable.
The locking mechanism in this spinal plate system can become loose either during surgery or after the procedure. If it becomes loose, it may require additional surgery to replace or fix the plate, which could lead to complications.
Patients who received the CervAlign Anterior Cervical Plate System (4Level, 80mm) with material number 66-480 during surgery between certain batch dates are affected. Surgeons and medical staff using this product are at highest risk.
Check for the product name 'CervAlign Anterior Cervical Plate System (4Level, 80mm)' with material number 66-480. The affected batches are 342457, 348032, 351955, 357129, 364769, and 381292.
Identify the material number and batch numbers listed in the recall notice to confirm if your device is affected.
Reach out to your surgeon to determine if the recalled plate system was used in your procedure and whether additional action is needed.
The recall affects specific cervical plate systems used in spine surgery. Your surgeon can confirm if your procedure used the recalled model.
Contact your surgeon to discuss whether the plate needs replacement or revision due to potential locking mechanism issues.
Look for the material number 66-480 and batch numbers 342457, 348032, 351955, 357129, 364769, or 381292 on your device.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1233-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1233-2021 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.
