Z-0019-2020 Class II Terminated
FDA device recall Z-0019-2020 was initiated by Paltop Advanced Dental Solutions Ltd on May 30, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 9, 2020). Affected quantity: 167 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- May 30, 2019
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 units
Product Description
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Reason for Recall
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 Pattern
AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA
Code Information
Lot Number: W0-008254 UDI: 729010869611020-70024P