Recall Z-2929-2026— Straumann USA LLC

Name: FDA recall Z-2929-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-13

Class II · Ongoing

Class II FDA medical device recall by Straumann USA LLC, initiated 2026-07-13. It names one FDA 510(k) clearance: K163194. Product: GM Helix Implant, Endosseous Dental Implant Article No. 109.984. Reason: 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.

Recalling firm: Straumann USA LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-07-13
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, Endosseous Dental Implant Article No. 109.984

Reason for recall

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

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