Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (5 Level, 105mm) 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 is recalling a specific type of cervical plate system used in spinal surgery 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 the CervAlign plate system may become loose during surgery or after surgery. This could cause the plate to become unstable, requiring additional surgery to fix the problem.
Surgical patients who received the CervAlign Anterior Cervical Plate System (5 Level, 105mm) with batch numbers 345228, 352383, 357124, 364542, 370440, or 382120 are affected. Surgeons and hospitals using this specific product are most at risk.
Check if you have the CervAlign Anterior Cervical Plate System (5 Level, 105mm) with material number 66-5105 and batch numbers 345228, 352383, 357124, 364542, 370440, or 382120.
Identify the material number (66-5105) and batch numbers (345228, 352383, 357124, 364542, 370440, 382120) to confirm if your device is affected.
The locking mechanism may become loose during surgery or after surgery, requiring replacement or additional surgery.
Check the material number and batch numbers to see if your device is affected. If it is, contact Pioneer Surgical for further instructions.
The recall is due to the locking mechanism potentially becoming loose, which could require additional surgery. There is no specific mention of injury risk in normal use.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1237-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1237-2021 from Pioneer Surgical. 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.
