Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (5 Level, 90mm) with material number 66-590 due to locking mechanism disassociating during or after surgery, potentially requiring revision. 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) that may have a locking mechanism that becomes loose during or after surgery. This could require additional surgery to fix the problem.
The locking mechanism in this spinal plate system can become loose either during surgery or after the procedure. If it becomes loose, it may need to be replaced or revised through additional surgery.
Patients who received the CervAlign Anterior Cervical Plate System (5 Level, 90mm) with material number 66-590 during surgery are affected. Surgeons and medical staff who used this product are most at risk.
Check if your CervAlign Anterior Cervical Plate System has material number 66-590 and batch numbers 345225, 352380, 357121, 359852, 370419, or 382118. This product is used for spinal fusion procedures.
Identify the material number (66-590) and batch numbers listed in the recall notice to confirm if your device is affected.
Reach out to the surgeon who performed your procedure to discuss whether the recalled device was used and if any action is needed.
This recall is for patients who received the CervAlign Anterior Cervical Plate System during surgery. Medical professionals who used this product are also affected.
The affected batch numbers are 345225, 352380, 357121, 359852, 370419, and 382118.
No, the recall does not require immediate discontinuation. Patients should contact their surgeon to determine if the device needs replacement or revision.
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-1241-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1241-2021 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.
