Straumann Manufacturing, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0455-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 2, 2018

Date Posted: November 21, 2018

Recall Number: Z-0455-2019

Event ID: 81456

Reason for Recall:

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

Status: Terminated

Product Quantity: 21 units

Code Information:

Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated