Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (1 Level, 24m) with material number 66-124 due to locking mechanism disassociating during or after surgery, potentially requiring revision. Affected units include specific batch numbers.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology is recalling their CervAlign Anterior Cervical Plate System (1 Level, 24m) with material number 66-124. The locking mechanism may disassociate during or after surgery, requiring replacement or revision. This could lead to complications for patients who have undergone spinal surgery.
The locking mechanism in the CervAlign plate system can become detached either during surgery or after the procedure is completed. This disassociation may require additional surgery to fix the issue, which could lead to complications for patients.
Patients who have received the CervAlign Anterior Cervical Plate System (1 Level, 24m) with material number 66-124 for spinal fusion procedures are affected. Surgeons and medical facilities using the product are at risk of needing revisions.
Check for the product name 'CervAlign Anterior Cervical Plate System (1 Level, 24m)' with material number 66-124. Affected units include specific batch numbers: 329485, 338822, 341498, 344093, 348580, 353383, 363437, 364053, 369331, 372220, 379408.
Identify the material number (66-124) and batch numbers listed in the recall notice to confirm if your device is affected.
Reach out to Pioneer Surgical Technology directly for guidance on next steps if your device is confirmed affected.
The locking mechanism has been observed to disassociate either during or after surgery, potentially requiring replacement or revision.
Batch numbers 329485, 338822, 341498, 344093, 348580, 353383, 363437, 364053, 369331, 372220, and 379408 are affected.
The recall does not require immediate discontinuation; however, affected units may need revision if the locking mechanism disassociates.
We’ve drafted a message you can send Pioneer Surgical Technology to request your refund or repair — edit it as you like.
Subject: Recall Z-1210-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1210-2021 from Pioneer Surgical Technology. 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.
