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Terminated

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

FDA Recall Z-0455-2019 · Posted None

Recalling FirmStraumann Manufacturing, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2018-10-02
Date Terminated2019-01-28
Product Quantity21 units

Reason for Recall

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

Firm Action

Straumann sales reps. visited each account, retrieved and returned product to Straumann USA.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017-07-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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