Recall Z-0836-2020— Paltop Advanced Dental Solutions Ltd

Name: FDA recall Z-0836-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-18

Class II · Terminated

Class II FDA medical device recall by Paltop Advanced Dental Solutions Ltd, initiated 2019-11-18, terminated 2022-12-27. It names one FDA 510(k) clearance: K130462. Product: 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..

Recalling firm: Paltop Advanced Dental Solutions Ltd
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Terminated: 2022-12-27
Firm location: Caesarea, Israel

510(k) clearances named in this recall

1 on FDA's record

K130462 — PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANTPaltop Advanced Dental Solutions, Ltd.·cleared 2013-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.