Recall Z-1853-2020— Nobel Biocare Usa Llc
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: K974150. 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.. Reason: 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..
- 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 recordK-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
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.