Z-1987-2025Class II

Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to...

Name: Z-1987-2025 Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to...
Creator: Preat Corp
Published: 2025-04-02
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2025-04-02 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental... on 2025-04-02. FDA classified it as Class II and gives the reason as "Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the 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-1987-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-02
Posted: 2025-06-18
Recalling firm: PREAT Corporation
Product: Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 04/02/2025 an initial customer notification was distributed by the firm. On 05/05/2025, the firm sent via certified mail an updated "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter to customers informing them that due to manufacturing issues with a dimensional condition that may lead to no engagement between the prosthetic screw and the implant. Customer are instructed to discard or return the affected devices to PREAT Corporation. For questions, contact Quality Assurance at 800-232-7732 or email [email protected]
Quantity in commerce: 145 abutments
Distribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
Product codes and lots: Model Number: 9001767-F UDI-DI code: 00842092166093 Lot Numbers: CN932775 ED11-202416933 ED11-20249907 ED11-202435949 CN939348 ED11-202417239 ED11-202411745 ED11-202436404 CN945176 ED11-202419976 ED11-202413957 ED11-202437437 CN946712 ED11-202422121 ED11-202414696 ED11-202437710 TEC29015668 ED11-202422577 ED11-202416838 ED11-202437908 29018601 ED11-202428254 ED11-202433998 ED11-202449612 RD10511988 ED11-202428428 ED11-202435120 242070 2905742 ED11-20249819 ED11-202435909 20-607-UCHE-000603 8-663465-000743 3-16287-002239 14-493GARIEPY-000488 20-769300-000697 20-663461ROBI-000707 30-15958-002006 7-804684-001981 13-766227-000633 6-662469CARM-000576 20-15117-001341 22-790909-001273 8-489686-000448 30-Y097-002143 19-14364-001061 10-788120-001206 7-754951-000206 3-RIEHL-001837 CO19-2024-91576 CO19-2024-68877 CO19-2024-36953 CO19-2024-24127

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1987-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1987-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-18

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)