The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1987-2025·Announced 2025-06-25

Biomet 3i Certain-Compatible 4.1mm Milled Titanium Dental Abutments

Preat Corp is recalling Biomet 3i Certain-compatible 4.1mm Milled Titanium Abutments (Model 9001767-F) due to manufacturing defects that may cause improper screw engagement. The screw seat was positioned too high, potentially compromising the attachment of mating screws to the underlying implant.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a risk-of-harm defect (improper screw engagement that could compromise prosthetic stability). No reported illnesses or injuries are stated in the source, so the score does not exceed 3 per the rubric.

Plain-English summary

Preat Corp is recalling 145 Biomet 3i Certain-compatible 4.1mm Milled Titanium Abutments (Model Number 9001767-F, UDI-DI: 00842092166093) distributed nationwide to dental practices in Arizona, California, Georgia, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, and Washington.

The recalled abutments were manufactured with the screw seat positioned too high. This defect may cause the mating screw to have insufficient engagement length when inserted into the associated endosseous dental implant, potentially affecting the stability of single-unit or multi-unit prosthetic restorations.

Affected lot numbers are: 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, and CO19-2024-24127.

Dental professionals who have received these abutments should discontinue use and contact Preat Corp for instructions regarding return or replacement. Patients who have received restorations using these abutments should be advised to contact their dental provider.

The recalled product

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.
Manufacturer
Preat Corp
Category
Medical Device — Dental / Implant Components
Hazard
Affected units
145

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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