Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (4Level, 84mm) due to locking mechanism disassociation during surgery 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 spinal surgeries because its locking mechanism can become detached during or after surgery. This could lead to needing additional surgery to fix the issue.
The locking mechanism in this spinal plate system can become detached either during surgery or after surgery. This disassociation may require additional surgery to replace or revise the device.
Surgical patients who received the CervAlign Anterior Cervical Plate System (4Level, 84mm) with material number 66-484 and batch numbers 342458 through 381526 are affected. Surgeons and hospitals using this product are most at risk.
Check for the product name 'CervAlign Anterior Cervical Plate System (4Level, 84mm)' with material number 66-484 and batch numbers 342458, 348033, 351956, 357130, 364770, 370416, or 381526.
Verify the material number (66-484) and batch numbers listed in the recall notice.
The locking mechanism has been observed to disassociate either during surgery or after surgery, potentially requiring replacement or revision surgery.
The recall notice does not specify a remedy; check the product details to confirm if it's affected and contact Pioneer Surgical for guidance.
The recall notice does not specify which hospitals or surgeons use this product.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1234-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1234-2021 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.
