Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (1 Level, 22mm) 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 a specific type of cervical plate system used in spinal surgery because its locking mechanism can become loose during or after surgery. This could require additional surgery to fix the problem.
The locking mechanism in this spinal plate system can become loose either during surgery or after the procedure. If it becomes loose, it may require additional surgery to replace or revise the device.
Surgical patients who received the CervAlign Anterior Cervical Plate System (1 Level, 22mm) with the listed batch numbers. Surgeons and hospitals using this product are most at risk.
Check if your device has the model name 'CervAlign Anterior Cervical Plate System' (1 Level, 22mm) and batch numbers 329484, 338821, 341497, 344092, 348579, 353382, 363436, 367789, 372223, 372224, or 379407.
Identify if your device has the model name 'CervAlign Anterior Cervical Plate System' (1 Level, 22mm) and the listed batch numbers.
Reach out to Pioneer Surgical for replacement or revision options.
The locking mechanism in this spinal plate system can become loose during surgery or after the procedure, potentially requiring additional surgery to fix.
Batch numbers 329484, 338821, 341497, 344092, 348579, 353382, 363436, 367789, 372223, 372224, and 379407.
No, but you should check if your device is affected and contact Pioneer Surgical for replacement or revision options.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1243-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1243-2021 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.
