TemporaryFDAOngoing
Can cause harm that is usually temporary.
GM Helix Implant, REF: 109.984;
Check the device or its packaging for
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- Why
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Distributed
- 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;
- Company
- Straumann USA LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3173-2026 · retrieved 15 September 2026
Read the official notice