Straumann USA LLC — GM Helix Implant, REF: 109.984;
Official product recall notices and clearly labeled enforcement reference records.
Reference record — not a live warning · enforcement-reference · official-source
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Posted by source
- Source last updated
- Current version retrieved
- Provider
- FDA — device enforcement reference
- Location
- Andover, MA, US
- hazard
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- notice
- Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
- product
- GM Helix Implant, REF: 109.984;
- 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;
- event number
- 99707
- manufacturer
- Straumann USA LLC
- recall number
- Z-3173-2026
- source status
- Open, Classified
- freshness minutes
- 180
Source use policy · openFDA reference data; not a real-time public alert service
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