Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (3Level, 51mm) due to locking mechanism disassociating during surgery or after. Affected units have specific batch numbers. Contact for remedy.
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 (3Level, 51mm) because the locking mechanism can become detached during surgery or after the procedure. This could require additional surgery or revision, which poses a risk to patients.
The locking mechanism in the CervAlign plate system can become detached either during surgery or after the procedure. This disassociation may require additional surgery or revision to fix the issue, which can be risky for patients.
Patients who received the CervAlign Anterior Cervical Plate System (3Level, 51mm) with specific batch numbers during surgery are affected. Surgeons and medical staff using the product are at highest risk.
Check if your CervAlign Anterior Cervical Plate System has the model number 66-351 and batch numbers listed in the recall (e.g., 333021, 333022, 338840, etc.). The product is used for neck surgeries to treat conditions like disc degeneration or spinal stenosis.
Reach out to Pioneer Surgical for specific instructions on how to handle the recalled product.
The recall states the locking mechanism may disassociate during surgery or after, which could require additional surgery. It is not safe to use without checking if it's recalled.
Batch numbers 333021, 333022, 338840, 341489, 343445, 346886, 351527, 351528, 358459, 362405, 363444, 364766, 369197, 370268, 377838, 379930, 379931, 385407 are affected.
The recall does not specify an immediate stop; the hazard requires monitoring for disassociation, so use caution.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1223-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1223-2021 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.
