Z-0018-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- July 26, 2021
- Termination Date
- September 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236
Product Description
Scan Abutment WP, Cat. No. 30-70106 - 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.
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 Pattern
US Nationwide distribution. No foreign distribution from US.
Code Information
All lots manufactured prior to July 21, 2021.