Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (2Level, 32mm) 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, 32mm) because the locking mechanism can become detached during surgery or after the procedure. This could lead to needing additional surgery or revision. Patients with the affected batch numbers should contact the company for a replacement.
The locking mechanism in the CervAlign plate system can become detached either during surgery or after the procedure. This disassociation may require additional surgery or revision to fix the issue.
Patients who received the CervAlign Anterior Cervical Plate System (2Level, 32mm) with specific batch numbers for spinal surgery are most at risk. This recall affects individuals who had the surgery using the recalled product.
Check the batch numbers on the product: 330973, 330975, 330976, 338830, 338831, 344099, 344100, 350516, 350517, 356798, 358456, 361803, 361804, 364749, 369336, 370393, 377188, 379018, 379542, 379543, 379544, 380874. The product is used for anterior cervical spine fixation in spinal surgeries.
Reach out to Pioneer Surgical to get a replacement for the affected CervAlign Anterior Cervical Plate System (2Level, 32mm) with the listed batch numbers.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, which may require additional surgery or revision.
The affected batch numbers are: 330973, 330975, 330976, 338830, 338831, 344099, 344100, 350516, 350517, 356798, 358456, 361803, 361804, 364749, 369336, 370393, 377188, 379018, 379542, 379543, 379544, 380874.
No, the recall does not require immediate discontinuation. Patients should contact Pioneer Surgical for a replacement.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1214-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1214-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
