Class II — Straumann USA LLC
| Recalling firm | Straumann USA LLC |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume |
| Product | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 |
| Quantity | 417 US |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. |
| Initiated | 2026-07-13 |
| Classified | 2026-08-10 |
| Recall number | Z-2929-2026 |
| 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-2929-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99407/
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