Nobel Biocare Usa Llc: 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.

Agency Publication Date: May 4, 2020

Affected Products

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 restore chewing function.

Catalog no. 36662, Lot no. 13078005, UDI: (01)07332747034301(10)13078005

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 restore chewing function.

Catalog no. 36664, Lot no. 13077622, UDI: (01)07332747034301(10)13077622

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 chewing function.

Catalog no. 36669, Lot no. 13077560, UDI: (01)07332747032598(10)13077560

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 restore chewing function.

Catalog no. 36683, Lot no. 13077700, UDI: (01)07332747034264(10)13077700

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.

Catalog no. 38214, Lot no. 13076822, UDI: (01)07332747096538(10)13076822

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.

Catalog no.38761, Lot numbers 13077550 and 13077551; UDI: (01)07332747115604(10)13077550 and (01)07332747115604(10)13077551

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85159

Status: Resolved

Manufacturer: Nobel Biocare Usa Llc

Manufactured In: United States

Units Affected: 6 products (236; 239; 227 pieces; 215 pieces; 238 pieces; 478 pieces)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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