Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (5 Level, 100mm) 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, 100mm) because the locking mechanism may become detached during surgery or after the procedure. This could require replacement or revision surgery, which is why it matters for patients who have had or are scheduled for spinal surgery.
The locking mechanism in the CervAlign plate system can become detached either during surgery or after the procedure. This detachment may require additional surgery to fix the issue, which can be more complex and risky than the original procedure.
Patients who have had or are scheduled for spinal surgery using the recalled CervAlign Anterior Cervical Plate System (5 Level, 100mm) with specific batch numbers are most at risk. Surgeons and medical facilities using the product are also affected.
Check if your CervAlign Anterior Cervical Plate System is 5 Level, 100mm with Material Number 66-5100. Affected units have batch numbers 345227, 352382, 357123, 364541, 372302, or 382119.
Identify if your CervAlign Anterior Cervical Plate System is 5 Level, 100mm with Material Number 66-5100 and the listed batch numbers.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, which may require replacement or revision surgery.
Batch numbers 345227, 352382, 357123, 364541, 372302, and 382119 are affected.
No, the recall does not require immediate discontinuation. However, patients with the affected product should contact their surgeon to discuss potential replacement or revision.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1236-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1236-2021 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.
