United StatesThe GM Helix Implant, Endosseous Dental Implant (Article No. 109.984; UDI‑DI 7899878024552, Lot MVXJ9) distributed by Straumann USA LLC and sold nationwide in the US (417 units) is being recalled. The implant may not match the outer carton label, which could cause bone compression or difficulty during installation in situations with sufficient bone volume.
What's being recalled
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Recalling firm: Straumann USA LLC, Andover, MA, United States.
How to identify it
UDI-DI 7899878024552 Lot MVXJ9
The 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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)