FDA Medical Device Recalls (openFDA)
Paltop Advanced Dental Solutions Ltd: Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
- Recall number
- Z-0019-2020
- Recalling firm
- Paltop Advanced Dental Solutions Ltd
- Product
- Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
- Status
- Terminated
- Initiated
- 2019-05-30
- Posted
- not on file
- Terminated
- 2020-06-09
- Reason
- 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.
- Root cause
- 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
- 167 units
- Distribution
- AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA
- Lot, serial or model codes
- Lot Number: W0-008254 UDI: 729010869611020-70024P
- 510(k) numbers
- ["K112795"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3009161350
- Firm city
- Caesarea
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28