Date Initiated by Firm |
May 30, 2019 |
Create Date |
October 01, 2019 |
Recall Status1 |
Terminated 3 on June 09, 2020 |
Recall Number |
Z-0019-2020 |
Recall Event ID |
83198 |
510(K)Number |
K112795
|
Product Classification |
Implant, endosseous, root-form - Product Code DZE
|
Product |
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P |
Code Information |
Lot Number: W0-008254 UDI: 729010869611020-70024P |
Recalling Firm/ Manufacturer |
Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
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. |
Quantity in Commerce |
167 units |
Distribution |
AL
AZ
CA
CO
FL
GA
MA
MD
MO
MT
NJ
NM
NY
OH
SC
VA |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = PALTOP ADVANCED DENTAL SOLUTIONS LTD
|