Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (5 Level, 75mm) with material number 66-575 due to locking mechanism disassociating during surgery or after. Affected batch numbers include 345222, 352337, 357118, 364543, 372238, 382115, 386005.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical Technology is recalling their CervAlign Anterior Cervical Plate System (5 Level, 75mm) with material number 66-575 because the locking mechanism can become loose during surgery or after surgery, potentially requiring replacement or revision. This recall affects patients who have undergone spinal surgery using these specific plates.
The locking mechanism in the CervAlign plate system can become loose either during surgery or after surgery. This may require the surgeon to replace or revise the plate, which could lead to additional surgery and complications.
Patients who received the CervAlign Anterior Cervical Plate System (5 Level, 75mm) with material number 66-575 during spinal surgery are affected. Surgeons and medical facilities using these plates are most at risk of needing additional procedures.
Check if your CervAlign Anterior Cervical Plate System is labeled with material number 66-575. Affected units were sold with batch numbers 345222, 352337, 357118, 364543, 372238, 382115, or 386005.
Look for the material number 66-575 and affected batch numbers on the product.
If you received this plate system during spinal surgery, contact your surgeon to discuss potential replacement or revision.
The locking mechanism has been observed to disassociate either during surgery or after surgery, which may require replacement or revision.
Batch numbers 345222, 352337, 357118, 364543, 372238, 382115, and 386005 are affected.
No, but if you received this plate system during spinal surgery, contact your surgeon to discuss potential replacement or revision.
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-1238-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1238-2021 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.
