Straumann USA LLC recalls GM Helix Implant
- Recalling company
- Straumann USA LLC
- Product
- GM Helix Implant, REF: 109.984;
- Reason
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 12, 2026
- Reported
- Sep 23, 2026
- 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;
- Status
- Ongoing
- Quantity
- 216
- Lot / codes
- REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- Company location
- Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3173-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3173-2026 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.