Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (2Level, 24mm) due to locking mechanism disassociating during surgery or after. Affected units have specific batch numbers. Contact for replacement.
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 (2Level, 24mm) 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, potentially leading to complications.
Patients who received the CervAlign Anterior Cervical Plate System (2Level, 24mm) with specific batch numbers during surgery are affected. Surgeons and medical staff using the product are at risk of needing additional procedures.
Check the batch numbers listed: 330510, 330511, 338826, 344094, 350507, 355018, 361793, 361794, 364054, 372180, 372181, 377184, 378427. The product is used for anterior cervical spine fixation in conditions like degenerative disc disease or spinal stenosis.
Look for batch numbers 330510, 330511, 338826, 344094, 350507, 355018, 361793, 361794, 364054, 372180, 372181, 377184, or 378427 on the product.
Reach out to Pioneer Surgical for a replacement or revision if you have the affected batch numbers.
It is used for anterior cervical spine fixation in conditions like degenerative disc disease, spinal stenosis, trauma, or spinal deformities.
The locking mechanism can become detached during surgery or after the procedure, requiring additional surgery or revision.
Batch numbers 330510, 330511, 338826, 344094, 350507, 355018, 361793, 361794, 364054, 372180, 372181, 377184, and 378427.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1211-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1211-2021 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.
