FDA Device Recall Z-0019-2020: Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2020.

Recall Res Number

Z-0019-2020

Recalling Firm / Manufacturer

Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel

FEI Number

3009161350

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-05-30

Date Posted

N/A

Date Terminated

2020-06-09

Product Code

DZE

Event Number

83198

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.

Action Details Keystone Dental Customer Relations initiated notification via phone calls to each impacted end user between May 30 and June 7, 2019. A market correction Letter issued to customers on June 11 via overnight Federal Express. Customer Relations Reply Forms are being used to document the communication and product status of each end user. Any unused Implants should be returned as soon as reasonably possible.

Distribution Pattern AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA

Code Information / Serial Numbers Lot Number: W0-008254 UDI: 729010869611020-70024P

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Medical Device Recall: Z-0019-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer