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Terminated

Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

FDA Recall Z-0019-2020 · Posted None

Recalling FirmPaltop Advanced Dental Solutions Ltd
Recall StatusTerminated
Product CodeDZE
Date Initiated2019-05-30
Date Terminated2020-06-09
Product Quantity167 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112795PALTOP DENTAL IMPLANT SYSTEMPaltop Advanced Dental Solutions, Ltd. · 2012-04-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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