Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (2Level, 28mm) 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 a specific cervical plate system used in spinal surgeries because its locking mechanism can become loose during or after surgery, requiring replacement. This poses a risk of needing additional surgery if the device becomes unstable.
The locking mechanism in this spinal plate system can become detached either during surgery or after the procedure. This could lead to the device becoming unstable, requiring additional surgery to fix the issue.
Surgical patients who received the CervAlign Anterior Cervical Plate System (2Level, 28mm) with the listed batch numbers during spinal surgery are affected. Surgeons and hospitals using this product are at risk of needing additional procedures.
Check if your device has the model name 'CervAlign Anterior Cervical Plate System (2Level, 28mm)' and the batch numbers listed: 330970, 330971, 338828, 340985, 344096, 350511, 350512, 352676, 355019, 361799, 364056, 367799, 369334, 370389, 372183, 372184, 378429, 378430.
Identify if your device has the model name 'CervAlign Anterior Cervical Plate System (2Level, 28mm)' and the listed batch numbers.
Reach out to Pioneer Surgical for guidance on next steps if your device is affected.
The locking mechanism in this spinal plate system can become detached during surgery or after the procedure, requiring replacement or additional surgery.
Batch numbers 330970, 330971, 338828, 340985, 344096, 350511, 350512, 352676, 355019, 361799, 364056, 367799, 369334, 370389, 372183, 372184, 378429, 378430.
No, but if your device has the affected batch numbers, contact Pioneer Surgical for guidance on next steps.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1213-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1213-2021 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.
