Pioneer Surgical Technology recalls CervAlign Anterior Cervical Plate System (2Level, 36mm) with material number 66-236 due to locking mechanism disassociation risk during surgery or after. Affected units include specific batch numbers.
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 (2Level, 36mm) because the locking mechanism can become disassociated during surgery or after surgery, potentially requiring replacement or revision. This recall affects patients who have received this specific surgical implant.
The locking mechanism in the CervAlign plate system can become disassociated either during surgery or after surgery. This disassociation may require the surgeon to replace or revise the implant, which can lead to additional complications or procedures.
Patients who received the CervAlign Anterior Cervical Plate System (2Level, 36mm) with material number 66-236 during surgery are affected. Surgeons and medical staff who used this product in procedures are most at risk.
Check for the product name 'CervAlign Anterior Cervical Plate System (2Level, 36mm)' with material number 66-236. Affected units include batch numbers 332500, 338833, 344102, 350520, 353384, 361807, 364751, 364752, 369338, 377190, 379080, and 380872.
Identify the material number (66-236) and batch numbers listed in the recall notice to confirm if your device is affected.
The locking mechanism has been observed to disassociate either intraoperatively or postoperatively, which may require replacement or revision of the implant.
Batch numbers 332500, 338833, 344102, 350520, 353384, 361807, 364751, 364752, 369338, 377190, 379080, and 380872 are affected.
No immediate stop is required, but if you have the affected product, you should check with your surgeon about 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-1216-2021 — Pioneer Surgical Technology Pioneer Surgical Technology Hello, I own a Pioneer Surgical Technology that is covered by recall Z-1216-2021 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.
