Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (1 Level, 12mm) with material number 66-112 due to locking mechanism disassociating during surgery or after. Affected batches include 328891-379400.
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 (1 Level, 12mm) because the locking mechanism can become loose during surgery or after surgery, potentially requiring replacement. This affects patients who had spinal surgery using this specific model.
The locking mechanism in the CervAlign plate system can become disassociated either during surgery or after surgery. This may require the surgeon to replace or revise the implant, which could lead to additional complications or procedures.
Patients who received spinal surgery using the recalled CervAlign Anterior Cervical Plate System (1 Level, 12mm) with material number 66-112 are affected. Surgeons and medical facilities that used this product during procedures are most at risk.
Check if your CervAlign Anterior Cervical Plate System is labeled with material number 66-112. The product was sold in batches numbered 328891 through 379400. This system is used for spinal fusion procedures.
Look for the material number 66-112 on the CervAlign Anterior Cervical Plate System.
If you received this product during surgery, contact your surgeon to discuss potential replacement or revision.
The locking mechanism has been observed to disassociate either intraoperatively or postoperatively, which may require replacement or revision of the implant.
Batches 328891, 328893, 328894, 338794, 340980, 341495, 344086, 347925, 347926, 352672, 358452, 363412, 363413, 364047, 367781, 369328, 370314, 372189, 372190, 379399, and 379400.
No, the product is not for consumer use but for surgical procedures. Patients should contact their surgeon if they received this product during surgery.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1205-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1205-2021 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.
