Recall Z-1994-2026— Straumann USA LLC

Name: FDA recall Z-1994-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Class II · Ongoing

Class II FDA medical device recall by Straumann USA LLC, initiated 2026-03-27. It names one FDA 510(k) clearance: K242686. Product: Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments. Reason: Includes an incorrect screw seat interface..

Recalling firm: Straumann USA LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-03-27
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K242686 — Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.·cleared 2024-12-04

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

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Reason for recall

Includes an incorrect screw seat interface.

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