United StatesGM Helix Implant, REF: 109.984 (Lot VZPF4; UDI (01)7899878024552(11)251122(17)301121(10)VZPF4) distributed nationwide in AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA and WI (216 units) is affected. It was recalled because there is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
What's being recalled
GM Helix Implant, REF: 109.984;
Recalling firm: Straumann USA LLC, Andover, MA, United States.
How to identify it
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
The hazard
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
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 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;
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)