Recall Z-1863-2025— Straumann USA LLC

Name: FDA recall Z-1863-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-01

Class II · Ongoing

Class II FDA medical device recall by Straumann USA LLC, initiated 2025-05-01. It names one FDA 510(k) clearance: K163194. Product: GM Helix Acqua Implant, Article Number: 140.985. Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead..

Recalling firm: Straumann USA LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-05-01
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 Acqua Implant, Article Number: 140.985

Reason for recall

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

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