Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (1 Level, 20mm) 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 their CervAlign Anterior Cervical Plate System (1 Level, 20mm) because the locking mechanism can become detached during surgery or after the procedure. This could require additional surgery or revision to fix the issue.
The locking mechanism in the CervAlign plate system can become detached either during surgery or after the procedure. This detachment may require additional surgery or revision to correct the issue, as the plate may not stay securely in place.
Surgical patients who received the CervAlign Anterior Cervical Plate System (1 Level, 20mm) with specific batch numbers during procedures. Patients who have had spinal surgery for conditions like degenerative disc disease or trauma are most at risk.
Check the batch numbers on the product: 329483, 338820, 344091, 348578, 353381, 363435, 364051, 367788, 372225, 372226, 379406. The product is used for anterior cervical spine fixation in procedures for conditions like degenerative disc disease or trauma.
Look for batch numbers 329483, 338820, 344091, 348578, 353381, 363435, 364051, 367788, 372225, 372226, or 379406 on the CervAlign Anterior Cervical Plate System (1 Level, 20mm).
The locking mechanism has been observed to disassociate either during surgery or after the procedure, which may require additional surgery or revision.
The CervAlign Anterior Cervical Plate System (1 Level, 20mm) with Material Number 66-120.
Check the batch numbers: 329483, 338820, 344091, 348578, 353381, 363435, 364051, 367788, 372225, 372226, or 379406.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1209-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1209-2021 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.
