NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
FDA device recall Z-2514-2025 · posted 2025-09-03 · Open, Classified
Recall details
- Recalling firm
- Preat Corp
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 11
- Distribution
- US Nationwide distribution in the states of NY, FL, PA, CA, OH.
- Date initiated
- 2025-06-25
- Date posted
- 2025-09-03
- Location
- Santa Maria, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Preat Abutments (K183518) | Preat Corporation | 2019-03-18 |