CLASS II Device recall · Reported 13 Oct 2021 · FDA Enforcement Report

Scan Abutment SP recalled by Paltop Advanced Dental

Paltop Advanced Dental Solutions is recalling Scan Abutment SP, distributed nationwide in the US. The recall was initiated on 26 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots manufactured prior to July 21, 2021.

Quantity recalled782

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-0013-2022
FDA event ID: 88576
Recalling firm: Paltop Advanced Dental Solutions, Caesarea
Classification: Class II
Status: Terminated
Recall initiated: 26 Jul 2021
FDA classified: 4 Oct 2021
Reported: 13 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Surgical Instruments

Timeline

26 Jul 2021	Recall initiated by company
4 Oct 2021	Classified by FDA	+70 days
13 Oct 2021	Published in enforcement report	+9 days

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

Reason for recall

Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Where it was distributed

US Nationwide distribution. No foreign distribution from US.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots manufactured prior to July 21, 2021.

Where was it sold?

US Nationwide distribution. No foreign distribution from US.

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.

Other products in this recall event

5 other products · FDA event 88576

Reported	Class	Recall	Company	Reason	Where
13 Oct 2021	CLASS II	Scan Abutment NP recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021	CLASS II	Scan Abutment WP recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021	CLASS II	Scan Abutment MU recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021	CLASS II	Scan Abutment SU recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021	CLASS II	Scan Abutment PCA recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide

Reported	Class	Recall	Company	Reason	Where
13 Oct 2021Device	CLASS II	Scan Abutment PCA recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021Device	CLASS II	Scan Abutment SU recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021Device	CLASS II	Scan Abutment MU recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021Device	CLASS II	Scan Abutment WP recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide
13 Oct 2021Device	CLASS II	Scan Abutment NP recalled by Paltop Advanced Dental	Paltop Advanced Dental Solutions	Processing Deviation	Nationwide

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