medical Class II Updated 2020-05-13

Nobel Biocare Usa Llc recalls Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactu

Recalled 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 replacements to restore chewing function.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog no.38761, Lot numbers 13077550 and 13077551; UDI: (01)07332747115604(10)13077550 and (01)07332747115604(10)13077551
View official government recall

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