Straumann Manufacturing, Inc. recalls Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be…

Recall date

October 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0455-2019

FDA classification

Class II

Brand / firm

Straumann Manufacturing, Inc.

Sold / distributed

US nationwide distribution in the states of GA, TX , VA.

Why it was recalled

Laser engraved label does not match with the item in the package

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244