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U.S. Department of Health and Human Services

Class 2 Device Recall NobelBiocare" TriLobecompatible WP X 6.0mm Engaging Titanium Base

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 Class 2 Device Recall NobelBiocare" TriLobecompatible WP X 6.0mm Engaging Titanium Basesee related information
Date Initiated by FirmJune 25, 2025
Date PostedSeptember 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2514-2025
Recall Event ID 97239
510(K)NumberK183518 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductNobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Code Information UDI-DI: 00842092169599. Lot: 277097
Recalling Firm/
Manufacturer		 Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information ContactMarlen Gonzales
800-232-7732
Manufacturer Reason
for Recall		Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
FDA Determined
Cause 2		Process control
ActionOn 06/25/2025, recall notices were mailed to customers who were asked to do the following: 1) Stop/cease use of the product in the scope of this recall 2) This product shall be discarded or returned to the recalling firm 2) All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be notified be provided a copy of this notification and informed to notify their customers. 3) Complete and return the Customer Response Form via email to mgonzales@younginnovations.com If you have any questions or concerns, please call/email the firm at: (800) 232-7732, mgonzales@younginnovations.com
Quantity in Commerce11
DistributionUS Nationwide distribution in the states of NY, FL, PA, CA, OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHA
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