Z-0015-2022 Class II Terminated
FDA device recall Z-0015-2022 was initiated by Paltop Advanced Dental Solutions Ltd on July 26, 2021 and is designated Class II. 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 ha… The recall status is terminated (terminated September 21, 2023). Affected quantity: 337.
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
- 337
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.
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.