FDAAugust 12, 2026
Straumann GM Helix Implant Recall Over Packaging Discrepancy
FDA published this notice on August 12, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- August 12, 2026
- Recall class
- Class II
- Reason given by the agency
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- 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;
- Official source
- the notice at its source
Official warnings by state, with every type counted since 2008Search notices, places and declaration numbers
Source: FDA.