Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (2Level, 26mm) due to locking mechanism disassociating during surgery or after. Affected units have 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 for neck surgery. The locking mechanism may become loose during or after surgery, requiring replacement. This could lead to the need for additional surgery.
The locking mechanism in the plate system can become loose either during surgery or after the procedure. This may require the surgeon to replace or revise the implant, which could lead to additional surgery.
Surgical patients who received the CervAlign Anterior Cervical Plate System (2Level, 26mm) with specific batch numbers during neck surgery. Surgeons and hospitals using this product are most at risk.
Check the batch numbers listed: 330512, 330513, 338827, 340984, 344095, 350509, 350510, 352675, 361797, 364055, 364747, 367798, 370387, 372182, 377185, 378428. The product is used for neck surgery to fix spinal issues.
Look for the batch numbers listed: 330512, 330513, 338827, 340984, 344095, 350509, 350510, 352675, 361797, 364055, 364747, 367798, 370387, 372182, 377185, 378428.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, which may require replacement or revision of the implant.
Check the batch numbers listed in the recall notice. If you have the affected batch numbers, contact Pioneer Surgical Technology for guidance.
The recall is due to the locking mechanism potentially becoming loose, which may require additional surgery. There is no mention of immediate injury risk in normal use.
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-1212-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1212-2021 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.
