Reported Sep 23, 2026 · Ongoing
GM Helix Implant, REF: 109.984;
Straumann USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann USA LLC · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- GM Helix Implant
- REF109.984
- Lot codes and dates
- REF109.984
- UDI(01)7899878024552(11)251122(17)301121(10)VZPF4
- LotVZPF4
- Amount recalled
- 216
Where it was sold
Why it was recalled
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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