Straumann USA LLC recalls GM Helix Implant
- Recalling company
- Straumann USA LLC
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- 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
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 13, 2026
- Reported
- Aug 19, 2026
- 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.
- Status
- Ongoing
- Quantity
- 417 US
- Lot / codes
- UDI-DI 7899878024552 Lot MVXJ9
- Company location
- Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2929-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2929-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.