Z-1321-2024Class II

Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

Name: Z-1321-2024 Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Creator: Preat Corp
Published: 2024-02-09
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2024-02-09 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 on 2024-02-09. FDA classified it as Class II and gives the reason as "Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant". 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-1321-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-09
Posted: 2024-03-20
Recalling firm: PREAT Corporation
Product: Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On 02/09/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via US certified mail to customers to inform them that the abutment was manufactured with a dimensional condition that may lead to reduced engagement between the prosthetic screw and the implant. Customer are instructed to inspect their inventory and discard or return the affected products to PREAT CORPORATION. For questions or further assistance contact the Quality Assurance Manager at 800-232-7732 or email at [email protected] On 2/16/2024, the firm sent via certified USPS mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" which informs customer to notify all personnel within their company, and of their customers where the affected products may have been further distributed of the recall.
Quantity in commerce: 561 units
Distribution: U.S. Nationwide distribution in the states of AZ, OH and PA.
Product codes and lots: Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1321-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-20

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)