Recall Z-2514-2025— Preat Corp
Class II · Ongoing
Class II FDA medical device recall by Preat Corp, initiated 2025-06-25. It names one FDA 510(k) clearance: K183518. Product: NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662. 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..
- Recalling firm
- Preat Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-25
- Firm location
- Santa Maria, 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
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.