FDAClass IIOctober 13, 2021

Scan Abutment NP recall

Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital…

Why was Scan Abutment NP recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots manufactured prior to July 21, 2021.

Product
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital…
Recalling firm
Paltop Advanced Dental Solutions Ltd
Quantity
354
Distribution
US Nationwide distribution. No foreign distribution from US.
Recall date
October 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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