FDA Class II recall: GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
A Class II recall of the Straumann GM Helix Implant (Article No. 109.984) means US dental practices risk placing the wrong implant, potentially causing bone compression or insertion failure; owners, specialists, and DSO implant teams must verify every unit before use.
Key points
- Recall number Z-2929-2026 is ongoing and covers nationwide distribution to 18 states.
- Mismatch between the implant inside the package and the label on the outer carton is the defect.
- Incorrect implant placement can lead to bone compression or surgical difficulty when bone volume is adequate.
- Practices should immediately quarantine all Straumann GM Helix Implant Article No. 109.984 units and contact Straumann USA LLC for verification and replacement.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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