The Recall Desk

FDA (Devices) recall action 88576

Paltop Advanced Dental Solutions Ltd recalled 6 products on 2021-10-13

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2021-10-13
Critical
0
Units
1,793

Why these products were recalled

Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • ModerateFDA (Devices)··2021-10-13

    Scan Abutment PCA dental implant component recalled for tolerance deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment PCA devices due to manufacturing tolerance deviations that may delay implant restoration. Some devices show up to 2-degree orientation variance and sizing discrepancies.

    Product
    Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgic
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-10-13

    Paltop Scan Abutment MU devices recalled for manufacturing tolerance deviations

    Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.

    Product
    Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-10-13

    Dental implant scan abutment recalled for dimensional tolerance and marking defects

    Paltop Scan Abutment WP dental implant scanning devices are recalled due to manufacturing defects. Affected units show dimensional tolerance deviations and size marking incongruences that may delay restoration procedures.

    Product
    Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-10-13

    Paltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.

    Product
    Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-10-13

    Scan Abutment NP Dental Implant Components Recalled for Dimensional Deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment NP dental implant components due to manufacturing tolerance deviations that may affect implant restoration fit and timing.

    Product
    Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-10-13

    Dental implant abutments recalled for orientation and sizing tolerance issues

    Paltop Advanced Dental Solutions is recalling Scan Abutment SU devices (Catalog No. 30-70104) manufactured before July 21, 2021, due to manufacturing tolerance deviations that may delay dental restoration.

    Product
    Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
    Category
    Distribution
    0 states