Z-2514-2025Class II

NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

Name: Z-2514-2025 NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Creator: Preat Corp
Published: 2025-06-25
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2025-06-25 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 on 2025-06-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2514-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-25
Posted: 2025-09-03
Recalling firm: PREAT Corporation
Product: NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Product code: NHA Abutment, Implant, Dental, Endosseous
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.
Root cause tag: manufacturing process
FDA 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 [email protected] If you have any questions or concerns, please call/email the firm at: (800) 232-7732, [email protected]
Quantity in commerce: 11
Distribution: US Nationwide distribution in the states of NY, FL, PA, CA, OH.
Product codes and lots: UDI-DI: 00842092169599. Lot: 277097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2514-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2514-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03

Product code NHA

K183518Class IIPreat AbutmentsPreat Corporation / cleared 2019-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)