Warning
Straumann USA LLC Recalls Straumann n!ce PMMA Full-arch Restoration
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1994-2026Medical Device
Straumann USA LLC Recalls Straumann n!ce PMMA Full-arch Restoration
Straumann USA LLC · Class II — Moderate Risk
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.
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.
Sources: FDA openFDA Enforcement Database