FDA Medical devices recall · August 19, 2026

GM Helix Implant, Endosseous Dental Implant Article No recall

Read the official FDA notice ↗

Product

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI 7899878024552 Lot MVXJ9

Distribution

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.

States: Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi Montana North Carolina New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia Washington Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2929-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.