Z-2318-2024Class II

9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an...

Name: Z-2318-2024 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an...
Creator: Preat Corp
Published: 2024-04-10
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2024-04-10 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic... on 2024-04-10. FDA classified it as Class II and gives the reason as "Due to incorrect milled titanium abutment being packaged and labeled". 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-2318-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-10
Posted: 2024-07-08
Recalling firm: PREAT Corporation
Product: 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Due to incorrect milled titanium abutment being packaged and labeled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 05/21/2024, the firm sent via direct certified mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter to customers informing them that product labeled as part number 9006767-F Astra EV 4.8mm Milled Titanium Abutment may contain instead part number 9006667 Astra EV 4.2mm Milled Titanium Abutment. The potential risk identified was, the screw seat is higher than specified in the engineering drawings and required for full thread engagement with the implant. This condition reduces the screw thread engagement with the implant. Customer are instructed to: Product in the scope of this recall shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. 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. For questions or assistance contact Jose Espino at 224-622-7191 or email [email protected]
Quantity in commerce: 7 abutmens
Distribution: U.S.: CA, MO, and NV. O.U.S.: None
Product codes and lots: Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2318-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2318-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-08

Product code NHA

K220823Class IIPreat AbutmentsPreat Corporation / cleared 2022-10-26

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)