Recall Z-2514-2025 ยท NHA Abutment, Implant, Dental, Endosseous
Preat Corp
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
| Date | Sep 3, 2025 (initiated Jun 25, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 ca |
| Quantity | 11 |
| Distribution | US Nationwide distribution in the states of NY, FL, PA, CA, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183518 | Preat Abutments Preat Corporation, Mar 18, 2019 |