Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (3Level, 57mm) with material number 66-357 due to locking mechanism disassociation risk during surgery or after. Affected units include specific batch numbers.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology recalls a specific type of cervical spine plate system (CervAlign 3Level, 57mm) 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 cervical spine plate system can become disassociated during surgery or after the procedure. This means the plate might not stay securely in place, potentially requiring additional surgery to fix the issue.
Surgical patients who received the CervAlign Anterior Cervical Plate System with material number 66-357 and batch numbers listed in the recall are affected. Surgeons and medical staff using this product during procedures are at risk if the locking mechanism fails.
Check for the product name 'CervAlign Anterior Cervical Plate System' with model '3Level, 57mm' and material number 66-357. Affected units include batch numbers 333152, 338845, 341493, 347126, 351531, 355537, 359848, 364534, 364971, 369364, 370407, 378060, and 380152.
Identify the material number (66-357) and batch numbers listed in the recall to confirm if your device is affected.
Reach out to Pioneer Surgical Technology directly for guidance on next steps if your device is confirmed affected.
The locking mechanism in the CervAlign Anterior Cervical Plate System has been observed to disassociate during or after surgery, which could require additional procedures to fix.
Check the material number and batch numbers listed in the recall. If affected, contact Pioneer Surgical Technology for further instructions.
The product is not safe if the locking mechanism disassociates, which could lead to the need for additional surgery. Affected units should be checked and contacted for guidance.
We’ve drafted a message you can send Pioneer Surgical Technology to request your refund or repair — edit it as you like.
Subject: Recall Z-1225-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1225-2021 from Pioneer Surgical Technology. 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.
