Class II — Straumann USA LLC
| Recalling firm | Straumann USA LLC |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. |
| Product | GM Helix Implant, REF: 109.984; |
| Quantity | 216 |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI; |
| Initiated | 2026-08-12 |
| Classified | 2026-09-15 |
| Recall number | Z-3173-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Straumann USA LLC (Z-3173-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99707/
Alerts for Straumann USA LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.