Caesarea, Israel
Paltop Advanced Dental Solutions Ltd recalls
3 recalls recorded since 2018, most recently on 26 July 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 July 2021
- Terminated
- 21 September 2023
- 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 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0013-2022, Z-0014-2022, Z-0018-2022, Z-0015-2022, Z-0016-2022, Z-0017-2022
- 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 Dent
- 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 registration of an implant or abutment platform. The Paltop Advanced Dent
- 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 Den
- 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 Den
- Scan Abutment SU, Cat. No. 30-70104 - 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 Den
- Scan Abutment PCA, Cat. No. 30-70105 - 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 De
Terminated Class II Medical devices
- Recall started
- 18 November 2019
- Terminated
- 27 December 2022
- Reason
- Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.
- Distribution
- The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0836-2020
- Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Terminated Class II Medical devices
- Recall started
- 30 May 2019
- Terminated
- 9 June 2020
- Reason
- Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
- Distribution
- AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0019-2020
- Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.