Lower riskMedical device recall · FDA · Published April 27, 2021
Medtronic Sofamor Danek Braive Growth Modulation System Break-Off Set Screws Recall
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.
“Medtronic Sofamor Danek Braive Growth Modulation System Break-Off Set Screws Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62698-medtronic-sofamor-danek-braive-growth-modulation-system-break-off-set. Based on FDA recall #Z-1797-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1797-2021%22&limit=1).
The FDA announced on April 27, 2021, that Medtronic Sofamor Danek USA Inc voluntarily recalled Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect from manufacturing issues. The recall affects 162 units distributed internationally in France, Switzerland, and Jordan.
How to tell if you have it
Brand: Medtronic Sofamor Danek
Product: Braive Growth Modulation System Break-Off Set Screws
Model numbers: CT20L012, CT20L020
Lot codes/dates: CT20L012 EXP 2 DEC 2028, CT20L020 EXP 11 DEC 2028
Quantity: 162 units
The hazard
The product is impacted by a thread profile defect due to a manufacturing issue. The record provides no information on incidents or injuries.
Context
GovInfoNow's records show Medtronic Sofamor Danek USA Inc has 19 other recalls on record since December 6, 2017. Other recent recalls include the September 16, 2025, recall of Medtronic 6069073 for potential cage collapse and the July 31, 2023, recall of Magnifuse Bone Graft due to incorrect labeling. Similar product recalls reported in August 2026 include SeaSpine Mariner Deformity Product for thread depth issues and Zimmer Off-Axis Shoulder System for plastic guide breakage.
How to tell if you have this one
Check for model numbers CT20L012 or CT20L020 on the Braive Growth Modulation System Break-Off Set Screws. These products were sold until December 2028.
Brand
Medtronic Sofamor Danek
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Identify if your screws are model CT20L012 or CT20L020.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1797-2021 (April 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1797-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.