medical Class II Updated 2020-05-13

Nobel Biocare Usa Llc recalls Universal Base CC RP 1.5 mm; The Universal Base Abutment in

Recalled 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 are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog no. 38214, Lot no. 13076822, UDI: (01)07332747096538(10)13076822
View official government recall

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