FDA Enforcement
Class II
Terminated
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Recall: Z-0836-2020
·
Reported January 29, 2020
Enforcement
- Recall Number
- Z-0836-2020
- Event ID
- 84412
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Paltop Advanced Dental Solutions Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 29, 2020
- Initiation Date
- November 18, 2019
- Classification Date
- January 21, 2020
- Termination Date
- December 27, 2022
- Address
- 5, Ha-Shita, Caesarea, N/A, Israel
Description
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
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.
Code Info
UDI: 07290108695649; Lot Number WO-011320
Distribution
The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.
Quantity
67