Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (4Level, 60mm) 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 (4Level, 60mm) because the locking mechanism can become loose during surgery or after the procedure, potentially requiring additional surgery. This recall affects patients who have had spinal surgery using this specific model.
The locking mechanism in this spinal plate system can become loose either during surgery or after the procedure. This may require additional surgery to fix the issue, which can be more complex and carry additional risks.
Patients who received the CervAlign Anterior Cervical Plate System (4Level, 60mm) with batch numbers 342452, 348027, 351950, 357125, 364537, 380155, 380156, or 385417 are affected. Surgeons and medical staff who used this product in spinal procedures are most at risk.
Check the batch number on the product label. Affected units have batch numbers: 342452, 348027, 351950, 357125, 364537, 380155, 380156, or 385417. The product is used for anterior cervical spine fixation in spinal surgeries.
Look for the batch number on the product label to determine if it is affected. Affected batch numbers are 342452, 348027, 351950, 357125, 364537, 380155, 380156, or 385417.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, which may require additional surgery.
The recalled product is the CervAlign Anterior Cervical Plate System (4Level, 60mm) with material number 66-460.
No, but if you have the affected batch numbers, you should check with your surgeon about potential risks and 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-1228-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1228-2021 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.
