Reported Jun 4, 2025 · Ongoing
GM Helix Acqua Implant, Article Number: 140.984
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 Acqua Implant
- Article Number140.984
- Lot codes and dates
- Article Number140.984
- UDI-DI(01)7899878025290(11)220122(17)260121(10)JPZ21
- Lot numberJPZ21
- Amount recalled
- 300 units (125 US, 175 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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