GM Helix Implant, Endosseous Dental Implant Article No. 109.984
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
| Recalling firm | Straumann USA LLC |
|---|---|
| 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 |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 19, 2026 |
| Initiated | Jul 13, 2026 |
| Region | MA, United States |
| 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. |
| Quantity | 417 US |
| Code/Lot | UDI-DI 7899878024552 Lot MVXJ9 |
| Type | Voluntary: Firm initiated |
| Recall number | Z-2929-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-2929-2026)
openFDA (U.S. Food & Drug Administration) — food/drug/device enforcement · CC0 1.0 (public domain)
Find out more
- Search this recall on FDA fda.gov ↗
- Search related news (Google News) news.google.com ↗
- Search this product (Google) google.com ↗
The links above open external searches by recall number / product name; the results are the responsibility of each site.
This page summarizes U.S. FDA data for general information and is not medical advice. Confirm details via official FDA announcements and the manufacturer.