Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (1 level, 18mm) due to locking mechanism disassociating during surgery or after. Affected units have batch numbers 329481-329482. Contact for replacement.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology recalls a specific cervical plate system for spinal surgery due to a locking mechanism that may become loose during or after surgery. This could require additional surgery or revision. The recall affects patients who received this specific model with batch numbers 329481 or 329482.
The locking mechanism in this spinal plate system can become loose during surgery or after surgery. This may require additional surgery or revision to fix the problem. The hazard is related to the device's function during spinal fusion procedures.
Patients who received the CervAlign Anterior Cervical Plate System (1 level, 18mm) with batch numbers 329481 or 329482 for spinal surgery are affected. Surgeons and surgical teams using this specific model are most at risk.
Check for the product name 'CervAlign Anterior Cervical Plate System (1 level, 18mm)' with material number 66-118. Affected units have batch numbers 329481 or 329482.
Reach out to Pioneer Surgical Technology for guidance on next steps and potential replacement.
The locking mechanism has been observed to disassociate either during surgery or after surgery, which may require replacement or revision surgery.
Contact Pioneer Surgical Technology for guidance on next steps and potential replacement.
Batch numbers 329481 and 329482.
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-1208-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1208-2021 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.
