Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (3 Level, 48mm) 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 their CervAlign Anterior Cervical Plate System (3 Level, 48mm) because the locking mechanism can become detached during surgery or after the procedure. This could require replacement or revision surgery, which is why it's important to check if your device is affected.
The locking mechanism in the CervAlign plate can become detached either during surgery or after the procedure. This detachment may require additional surgery to replace or revise the device, which can be more complex and carry additional risks.
Surgical patients who received the CervAlign Anterior Cervical Plate System (3 Level, 48mm) with specific batch numbers during procedures for neck conditions like degenerative disc disease or spinal stenosis. Surgeons and medical staff using the product are most at risk.
Check if your CervAlign Anterior Cervical Plate System (3 Level, 48mm) has the batch numbers listed: 333019, 333020, 338839, 341491, 346885, 351526, 354405, 359842, 359843, 363443, 364532, 369362, 370404, 377837, 379929, or 385416.
Look for the batch numbers listed: 333019, 333020, 338839, 341491, 346885, 351526, 354405, 359842, 359843, 363443, 364532, 369362, 370404, 377837, 379929, or 385416.
The locking mechanism in the CervAlign Anterior Cervical Plate System can become detached either during surgery or after the procedure, which may require additional surgery to replace or revise the device.
Check if your device has the specific batch numbers listed in the recall notice. If it does, contact Pioneer Surgical Technology for further instructions.
The recall states that the locking mechanism may disassociate, which could require replacement or revision surgery. This is a medical risk, but the recall does not specify that it causes serious injury 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-1222-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1222-2021 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.
