Home / Recalls / Medical Devices
Straumann USA LLC recalls GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Recalled August 19, 2026 · FDA recall Z-2929-2026 · Straumann USA
Hazard
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume · FDA Class II
Units
417 US
Sold at
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Description
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
Product
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Manufacturer(s)
Straumann USA LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →