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Straumann USA

18 recalls •
🏥 Medical Devices
• Categories: Implants & Prosthetics, Other Medical Devices, Surgical Instruments

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

Class I - Dangerous

A material mix-up had occurred during the manufacturing of StraumannÂż Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Mar 17, 2026 Other Medical Devices Nationwide View Details →

Straumann Bone Level Implant 04.1 mm RC, SLActiveÂż 8mm, RoxolidÂż, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used

Class I - Dangerous

Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

Sep 24, 2014 Implants & Prosthetics Nationwide View Details →

Straumann Bone Level Tapered Implant 04.1 mm RC, SLActiveÂż 8mm, RoxolidÂż, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.

Class I - Dangerous

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

Sep 19, 2014 Implants & Prosthetics View Details →

Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

Class I - Dangerous

Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2

Jul 11, 2012 Implants & Prosthetics Nationwide View Details →