Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (2Level, 40mm) with material number 66-240 due to locking mechanism disassociating during surgery or after. Affected batches include 332505, 338835, 344104, 350522, 354403, 361810, 367193, 370399, 379082.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical is recalling the CervAlign Anterior Cervical Plate System (2Level, 40mm) with material number 66-240 because its locking mechanism may disassociate during surgery or after surgery, requiring replacement or revision. This could lead to complications if the plate becomes unstable after spinal surgery.
The locking mechanism in the CervAlign plate system can become detached either during surgery or after the procedure. This disassociation may cause the plate to become unstable, requiring additional surgery to fix the issue.
Patients who received this specific spinal implant during surgery are affected. Surgeons and medical facilities using the recalled product are at highest risk for complications requiring additional procedures.
Check for the product name 'CervAlign Anterior Cervical Plate System (2Level, 40mm)' with material number 66-240. Affected batches include 332505, 338835, 344104, 350522, 354403, 361810, 367193, 370399, and 379082.
Identify the material number and batch numbers listed in the recall notice to confirm if your device is affected.
Reach out to your surgeon to determine if you received the recalled CervAlign plate system and whether a revision is needed.
The locking mechanism in the CervAlign Anterior Cervical Plate System (2Level, 40mm) may disassociate during surgery or after surgery, requiring replacement or revision.
Batches 332505, 338835, 344104, 350522, 354403, 361810, 367193, 370399, and 379082 are affected.
No, the recall does not require immediate discontinuation. Patients should contact their surgeon to determine if a revision is needed.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1218-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1218-2021 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.
