The Recall Desk

FDA (Devices) recall action 85159

Nobel Biocare Usa Llc recalled 6 products on 2020-05-13

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
2020-05-13
Critical
0
Units
1,633

Why these products were recalled

Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

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.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 215 Snappy Abutment 5.5 CC RP 3 mm units because they may contain incorrect screws that could loosen.

    Product
    Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
    Category
    Distribution
    31 states
  • ModerateFDA (Devices)··2020-05-13

    Nobel Biocare Universal Base Abutments Recalled for Incorrect Screws

    Nobel Biocare is recalling 238 Universal Base CC RP 1.5 mm abutments because they may contain incorrect screws that could loosen.

    Product
    Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments…
    Category
    Distribution
    31 states
  • ModerateFDA (Devices)··2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 478 Temporary Snap Abutments because packages may contain incorrect screws that could loosen, requiring retightening.

    Product
    Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth…
    Category
    Distribution
    31 states
  • ModerateFDA (Devices)··2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 239 units of Temporary Abutment Engaging CC RP components because packages may contain incorrect screws that could loosen.

    Product
    Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
    Category
    Distribution
    31 states
  • ModerateFDA (Devices)··2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 236 units of temporary dental implant abutments because packages may contain an incorrect screw that could loosen.

    Product
    Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
    Category
    Distribution
    31 states
  • ModerateFDA (Devices)··2020-05-13

    Nobel Biocare Recalls Dental Abutments Due to Incorrect Screw Risk

    Nobel Biocare is recalling 227 Esthetic Abutment CC RP 1.5 mm units because they may contain incorrect screws that could loosen.

    Product
    Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore…
    Category
    Distribution
    31 states