CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report

Neodent¿ GM Mini Conical Abutment recalled by Straumann Manufacturing

Straumann Manufacturing is recalling Neodent¿ GM Mini Conical Abutment, distributed nationwide in the US. The recall was initiated on 2 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510

Quantity recalled21 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0455-2019
FDA event ID: 81456
Recalling firm: Straumann Manufacturing, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 2 Oct 2018
FDA classified: 13 Nov 2018
Reported: 21 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

2 Oct 2018	Recall initiated by company
13 Nov 2018	Classified by FDA	+42 days
21 Nov 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Georgia Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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