Medtronic Sofamor Danek recalls Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect from manufacturing. Affected models CT20L012 and CT20L020 sold until December 2028.
Product is impacted by a thread profile defect due to a manufacturing issue.
Medtronic Sofamor Danek is recalling Braive Growth Modulation System Break-Off Set Screws because of a thread profile defect from manufacturing. This defect could cause improper function during spinal correction procedures.
The thread profile defect may cause the screws to fail during spinal correction procedures. This could lead to improper spinal alignment or reduced effectiveness of the treatment.
Patients receiving spinal correction treatment with the Braive system are most at risk. The recall affects specific model numbers CT20L012 and CT20L020.
Check for model numbers CT20L012 or CT20L020 on the Braive Growth Modulation System Break-Off Set Screws. These products were sold until December 2028.
Identify if your screws are model CT20L012 or CT20L020.
The screws have a thread profile defect due to a manufacturing issue.
CT20L012 and CT20L020 models.
Until December 2028.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-1797-2021 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-1797-2021 from Medtronic Sofamor Danek. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
