Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical s
Summary
The FDA issued a Class II for Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression by Paltop Advanced Dental Solutions Ltd. Reason: 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 inc.
Details
Source
Device Recall
External ID
Z-0015-2022
Action Date
2021-10-13
Status
Terminated
Category
device
Product Description
Scan Abutment MU, Cat. No. 30-70103 - 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.
Lot/Code Info: All lots manufactured prior to July 21, 2021.
Quantity Affected: 337
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.
Distribution
US Nationwide distribution. No foreign distribution from US.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-26
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Paltop Advanced Dental Solutions Ltd has 10 FDA actions in our database, including 6 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Paltop Advanced Dental Solutions Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Paltop Advanced Dental Solutions Ltd have FDA actions?
Paltop Advanced Dental Solutions Ltd has 10 FDA actions in our database, including 6 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0015-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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