Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (1 Level, 14mm) with material number 66-114 due to locking mechanism disassociating during or after surgery, potentially requiring revision. Affected units include batch numbers 328895-328:897.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Pioneer Surgical is recalling a specific type of cervical spine plate system that may become loose during or after surgery, requiring replacement. This could lead to additional surgery if the device becomes unstable.
The locking mechanism in this spinal plate system can become loose either during surgery or after the procedure. If it disassociates, the device may no longer stay securely in place, potentially requiring additional surgery to fix the issue.
Surgical patients who received the CervAlign Anterior Cervical Plate System (1 Level, 14mm) with material number 66-114 and batch numbers 328895-328897 are affected. Surgeons and medical staff using this product during procedures are most at risk.
Check for the product name 'CervAlign Anterior Cervical Plate System (1 Level, 14mm)' with material number 66-114 and batch numbers 328895, 328896, or 328897. This product is used for spinal fusion procedures.
Identify the material number (66-114) and batch numbers (328895-328897) on the device to confirm if it is affected.
The locking mechanism has been observed to disassociate either during or after surgery, which may require additional procedures to replace or revise the device.
Check the material number and batch numbers on the device. If it matches the recalled items (material number 66-114, batch numbers 328895-328897), contact Pioneer Surgical for further instructions.
The recall indicates that the device may become loose during or after surgery, potentially requiring additional procedures. However, the specific risk of serious injury is not detailed in the official notice.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1206-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1206-2021 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.
