Recall Z-3173-2026— Straumann USA LLC

Name: FDA recall Z-3173-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

Class II · Ongoing

Class II FDA medical device recall by Straumann USA LLC, initiated 2026-08-12. It names one FDA 510(k) clearance: K163194. Product: GM Helix Implant, REF: 109.984;. Reason: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside..

Recalling firm: Straumann USA LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-08-12
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K163194 — Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.·cleared 2017-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GM Helix Implant, REF: 109.984;

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.