Drugs & medicalClass II

Straumann USA LLC recalls GM Helix Implant, REF: 109.984;

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Read the official notice →
Date
2026-09-23
Country
United States
Brand
Straumann
Product
GM Helix Implant, REF: 109.984;
Classification
Class II
Units
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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