Z-0455-2019Class II

Neodent GM Mini Conical Abutment -

Name: Z-0455-2019 Neodent GM Mini Conical Abutment -
Creator: Straumann Manufacturing, Inc.
Published: 2018-10-02
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2018-10-02 / Terminated / root cause: manufacturing process

FDA source

Straumann Manufacturing, Inc. began a recall of Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the... on 2018-10-02. FDA classified it as Class II and gives the reason as "Laser engraved label does not match with the item in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0455-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-02
Posted: 2018-11-14
Terminated: 2019-01-28
Recalling firm: Straumann USA, LLC
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
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Laser engraved label does not match with the item in the package
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Straumann sales reps. visited each account, retrieved and returned product to Straumann USA.
Quantity in commerce: 21 units
Distribution: US nationwide distribution in the states of GA, TX , VA.
Product codes and lots: Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0455-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0455-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13

Product code DZE

K163194Class IINeodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. / cleared 2017-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)