Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (3 Level, 45mm) with Material Number 66-345 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 Technology recalls a specific type of cervical spine surgery plate system that may become loose during or after surgery. This could lead to the need for additional surgery to fix the problem.
The locking mechanism in this surgical 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.
Patients who received this specific cervical plate system during surgery are affected. Surgeons and surgical teams using this product are at highest risk.
Check for the product name 'CervAlign Anterior Cervical Plate System', 3 Level, 45mm, and Material Number 66-345. The batch numbers listed in the recall include 333017 through 379927.
Identify the product name, model, and batch numbers listed in the recall notice.
The locking mechanism has been observed to disassociate either during or after surgery, potentially requiring replacement or revision.
The official recall notice does not specify a remedy or action for affected patients or surgeons.
Batch numbers 333017, 333018, 338838, 346883, 346884, 351525, 354404, 358458, 359841, 364531, 369361, 370402, 377835, 377836, and 379927 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-1221-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1221-2021 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.
