Neodent GM Mini Conical Abutment - Product Usage: Mini… recallZ-0455-2019 · Straumann Manufacturing, Inc. · initiated Oct 2, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Straumann Manufacturing, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Laser engraved label does not match with the item in the package
FDA root cause category: Employee error
What the company is doing
Straumann sales reps. visited each account, retrieved and returned product to Straumann USA.
Recall details
- Recall number
- Z-0455-2019
- Status
- Terminated
- Initiated by the company
- Oct 2, 2018
- Recalling firm
- Straumann Manufacturing, Inc.
- Quantity
- 21 units
- Product code
- DZE
- FDA submissions
- K163194
- Distribution
- US nationwide distribution in the states of GA, TX , VA.
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
Code information (models, lots, serial numbers)
Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Neodent 115.244JJGC Indústria e Comércio de Materiais Dentários S/A. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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