Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (3Level, 60mm) with material number 66-360 due to locking mechanism disassociation risk during surgery or after. Affected batches include 333153, 338846, 341494, 347127, 351532, 359849, 364535, 364767, 369365, 370408, 378061, 380153.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology recalls their CervAlign Anterior Cervical Plate System (3Level, 60mm) with material number 66-360 because the locking mechanism can become disassociated during surgery or after surgery, potentially requiring replacement or revision. This risk affects patients who have received this specific surgical implant.
The locking mechanism in the CervAlign plate system can become disassociated either during surgery or after surgery. This disassociation may require the surgeon to replace or revise the implant, which could lead to additional surgical procedures.
Patients who received the CervAlign Anterior Cervical Plate System (3Level, 60mm) with material number 66-360 during surgery are most at risk. This recall applies to specific batch numbers listed in the official notice.
Check the material number on the product, which is 66-360. The affected batches include 333153, 338846, 341494, 347127, 351532, 359849, 364535, 364767, 369365, 370408, 378061, and 380153.
Identify the material number (66-360) and batch numbers listed in the recall notice to confirm if your device is affected.
This recall applies to the CervAlign Anterior Cervical Plate System (3Level, 60mm) with material number 66-360. If you received this specific implant during surgery, you may need to contact your surgeon about potential replacement or revision.
Check the material number and batch numbers listed in the recall notice to confirm if your device is affected. If it is, contact your surgeon to discuss potential replacement or revision.
Look for the material number 66-360 and check if your batch number is among the listed numbers: 333153, 338846, 341494, 347127, 351532, 359849, 364535, 364767, 369365, 370408, 378061, or 380153.
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-1226-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1226-2021 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.