Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (2Level, 34mm) with material number 66-234 due to locking mechanism disassociating during or after surgery, potentially requiring revision.
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 detached during or after surgery. This could require additional surgery to fix the problem.
The locking mechanism in the CervAlign plate system has been observed to become detached either during surgery or after the procedure. This detachment could lead to the need for additional surgery to replace or revise the device.
Patients who received this specific cervical plate system during surgery are affected. Surgeons and medical facilities using the product are most at risk.
Check if your cervical plate system has the model name 'Cervalign 2Level 34mm' and material number 66-234. The batch numbers listed in the recall include 330976 through 380689.
Identify if your device has the material number 66-234 and the listed batch numbers (330976-380689).
Reach out to Pioneer Surgical directly for guidance on next steps if you have the recalled product.
The locking mechanism has been observed to disassociate either during or after surgery, potentially requiring additional surgery to replace or revise the device.
Check if your device matches the material number 66-234 and batch numbers listed in the recall. Contact Pioneer Surgical for further instructions.
The product is not safe for use as recalled due to the risk of the locking mechanism becoming detached during or after surgery.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1215-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1215-2021 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.
