Recall Z-1856-2020— Nobel Biocare Usa Llc

Name: FDA recall Z-1856-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-09

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2019-08-09, terminated 2021-12-01. It names one FDA 510(k) clearance: K925762. 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.. Reason: 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..

Recalling firm: Nobel Biocare Usa Llc
Classification: Class II
Status: Terminated
Initiated: 2019-08-09
Terminated: 2021-12-01
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K925762 — BRANEMARK SYSTEM SELF-TAPPING FIXTURENobelpharma USA, Inc.·cleared 1993-10-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.