Pioneer Surgical recalls CervAlign Anterior Cervical Plate System (5 Level, 85mm) due to locking mechanism disassociating during surgery or after. Affected units have specific batch numbers. Contact for remedy.
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 (5 Level, 85mm) because the locking mechanism can become detached during surgery or after the procedure. This could require additional surgery or revision. Patients using this device should contact the manufacturer for guidance.
The locking mechanism in the CervAlign plate system can become detached during surgery or after the procedure. This disassociation may require additional surgery or revision to fix the issue.
Patients who received the CervAlign Anterior Cervical Plate System (5 Level, 85mm) with batch numbers 345224, 352339, 357120, 364544, 370418, or 382117 are affected. Surgeons and medical facilities using this device are most at risk.
Check the batch numbers on the product: 345224, 352339, 357120, 364544, 370418, or 382117. The product is a 5-level anterior cervical plate system used for neck conditions like degenerative disc disease.
Reach out to Pioneer Surgical for specific instructions on next steps for affected units.
The locking mechanism has been observed to disassociate either during surgery or after the procedure, which may require additional surgery or revision.
Batch numbers 345224, 352339, 357120, 364544, 370418, and 382117 are affected.
The recall does not specify a fix; affected users should contact Pioneer Surgical for guidance.
We’ve drafted a message you can send Pioneer Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1240-2021 — Pioneer Surgical Pioneer Surgical Hello, I own a Pioneer Surgical that is covered by recall Z-1240-2021 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.
