FDAFDA · Food and drugs·Recall number Z-0013-2022
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.
Published October 13, 2021 · Recall initiated: July 26, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Paltop Advanced Dental Solutions Ltd
- Distributor
- US Nationwide distribution. No foreign distribution from US.
- Lot
- All lots manufactured prior to July 21, 2021.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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