Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (3Level, 63mm) with material number 66-363 due to locking mechanism disassociation risk. 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 surgery plate system (CervAlign Anterior Cervical Plate System) 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 spinal plate system can become detached during surgery or after the procedure. This disassociation may cause the plate to become unstable, requiring additional surgery to fix the issue.
Surgical patients who received the recalled CervAlign Anterior Cervical Plate System (3Level, 63mm) with material number 66-363 during procedures between certain dates. Surgeons and hospitals using the product are most at risk for complications requiring additional surgery.
Check if your surgical plate has the model name 'CervAlign Anterior Cervical Plate System', 3Level, 63mm, and material number 66-363. Affected units include batch numbers 333154, 338847, 341490, 347128, 351533, 359850, 364536, 367817, 370409, 378062, and 380154.
Identify if your CervAlign Anterior Cervical Plate System has material number 66-363 and the listed batch numbers.
Reach out to Pioneer Surgical Technology for guidance on next steps if you have the recalled product.
The locking mechanism may disassociate during or after surgery, requiring replacement or revision surgery.
Batch numbers 333154, 338847, 341490, 347128, 351533, 359850, 364536, 367817, 370409, 378062, and 380154.
No, but if you have the recalled product, contact Pioneer Surgical Technology for guidance as the locking mechanism may become unstable.
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-1227-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1227-2021 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.
