Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (2Level, 38mm) 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 (2Level, 38mm) because the locking mechanism can become loose during surgery or after surgery, potentially requiring replacement. This recall affects patients who had this specific surgical implant.
The locking mechanism in this spinal implant can become loose either during surgery or after surgery. This may require the surgeon to replace or revise the implant, which could lead to complications in spinal stability.
Patients who received the CervAlign Anterior Cervical Plate System (2Level, 38mm) with batch numbers 332504 through 379081 are affected. Surgeons and patients who used this implant during spinal surgery are most at risk.
Check if your implant has the model name 'CervAlign Anterior Cervical Plate System (2Level, 38mm)' and batch numbers listed: 332504, 338834, 344103, 350521, 353385, 361808, 364753, 367807, 370398, or 379081.
Reach out to your surgeon to confirm if you received the recalled CervAlign Anterior Cervical Plate System (2Level, 38mm) with the listed batch numbers.
The locking mechanism has been observed to disassociate either during surgery or after surgery, which may require replacement or revision of the implant.
Batch numbers 332504, 338834, 344103, 350521, 353385, 361808, 364753, 367807, 370398, and 379081 are affected.
No, the recall does not require immediate discontinuation. Patients should contact their surgeon to determine if replacement or revision is needed.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1217-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1217-2021 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.
