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411 PRESS
WarningRecall #Z-1995-2026Medical Device

Straumann USA LLC Recalls Straumann n!ce Zr, HT, Full-arch Restoration

Straumann USA LLC · Class II — Moderate Risk

Hospital operating room medical equipment — representative photo for FDA medical device recall
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.

Product Description

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

Reason for Recall

Includes an incorrect screw seat interface.

FDA Classification

Class II — Moderate Risk

A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution

US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

411 Press Analysis

A Class II FDA recall has been issued for a medical device from Straumann USA LLC, initiated on March 27, 2026. Includes an incorrect screw seat interface. This recall covers 6 units, distributed nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.

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