Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (2Level, 30mm) due to locking mechanism disassociating during surgery or after. Affected units have specific batch numbers. Contact for replacement.
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, 30mm) because the locking mechanism can become loose during surgery or after the procedure, potentially requiring replacement or revision surgery. This recall affects patients who have undergone spinal surgery using this specific model.
The locking mechanism in the CervAlign plate system can become disassociated either during surgery or after the procedure. This may require additional surgery to replace or revise the implant, which can be a significant medical procedure.
Patients who received the CervAlign Anterior Cervical Plate System (2Level, 30mm) with specific batch numbers during spinal surgery are most at risk. This recall applies to those who had the procedure using the recalled model.
Check if your CervAlign Anterior Cervical Plate System (2Level, 30mm) has batch numbers 330972, 330973, 338829, 344097, 344098, 350514, 350515, 352677, 358455, 361801, 361802, 364748, 367803, 369335, 370391, 370392, 377187, 379016, 379539, 379540, or 379541.
Identify your CervAlign Anterior Cervical Plate System (2Level, 30mm) batch number from the list provided in the recall notice.
Reach out to Pioneer Surgical for guidance on whether your device needs replacement or revision surgery.
The locking mechanism in the CervAlign Anterior Cervical Plate System can become disassociated during surgery or after the procedure, potentially requiring replacement or revision surgery.
Batch numbers 330972, 330973, 338829, 344097, 344098, 350514, 350515, 352677, 358455, 361801, 361802, 364748, 367803, 369335, 370391, 370392, 377187, 379016, 379539, 379540, and 379541.
No, but you should contact Pioneer Surgical to determine if your device needs replacement or revision surgery.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1244-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1244-2021 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.
