Straumann USA LLC: GM Helix Implant, REF: 109.984;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Straumann USA LLC
- Product
- GM Helix Implant, REF: 109.984;
- Reason / hazard
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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;
- Recall initiated
- 2026-08-12
- Code info
- REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- Product quantity
- 216
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Andover
- State
- MA
- Country
- United States
- Event id
- 99707
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