FDA recall Z-0455-2019

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-10-02

Report date

2018-11-21

Termination date

2019-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0455-2019