NobelBiocare Tri-Lobe Titanium Base (Preat) – Positioning Error (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Brand
Preat Corp
Lot Codes / Batch Numbers
UDI-DI: 00842092169599. Lot: 277097
Products Sold
UDI-DI: 00842092169599. Lot: 277097
Preat Corp is recalling NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 due to Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the fla. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026