Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (5 Level, 95mm) 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 (5 Level, 95mm) because the locking mechanism can become detached during surgery or after surgery. 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 surgery. This detachment may require additional surgery or revision to fix the problem, which could lead to complications.
Patients who received the CervAlign Anterior Cervical Plate System (5 Level, 95mm) with specific batch numbers during surgery are affected. Surgeons and medical staff who used these implants are at highest risk.
Check the batch numbers on the product: 345226, 352381, 357122, 369366, 372235, or 381293. The product is used for anterior cervical spine fixation in patients with conditions like degenerative disc disease or spinal stenosis.
Reach out to your surgeon to discuss whether you received the recalled CervAlign Anterior Cervical Plate System with the listed batch numbers.
The locking mechanism has been observed to disassociate either during surgery or after surgery, which may require additional surgery or revision.
Batch numbers 345226, 352381, 357122, 369366, 372235, and 381293 are affected.
No, the recall does not require immediate discontinuation. Patients should contact their surgeon to determine if they received the affected product.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1242-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1242-2021 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.
