Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (3 Level, 42mm) with Material Number 66-342 due to locking mechanism disassociating during surgery or after surgery, requiring replacement.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology recalls a specific type of cervical plate system for spinal surgery. The locking mechanism may become loose during or after surgery, requiring replacement or revision. This could lead to improper spinal fixation and potential complications.
The locking mechanism in this spinal plate system can become disassociated either during surgery or after surgery. This means the plate may not stay securely in place, potentially causing improper spinal fixation and requiring additional surgery to fix the issue.
Surgical patients who received the recalled CervAlign Anterior Cervical Plate System (3 Level, 42mm) with Material Number 66-342 during procedures between certain batch dates. Surgeons and surgical teams using this specific product are most at risk.
Check if your CervAlign Anterior Cervical Plate System is labeled with Material Number 66-342. The product was sold with specific batch numbers: 333014, 333016, 338837, 341887, 343444, 346882, 351523, 355020, 361818, 364757, 367810, 369360, 370401, 372233, 379926.
Look for Material Number 66-342 on the product label to confirm if it is recalled.
Reach out to Pioneer Surgical Technology directly for guidance on next steps.
The locking mechanism has been observed to disassociate either during surgery or after surgery, which may require replacement or revision.
The recalled product has Material Number 66-342.
Batch numbers 333014, 333016, 338837, 341887, 343444, 346882, 351523, 355020, 361818, 364757, 367810, 369360, 370401, 372233, and 379926 are affected.
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-1220-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1220-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
