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RecallWatchMedical Device Safety
Class IIOngoingZ-1987-2025

Preat Corp recalls Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Ab…

Preat CorpSanta Maria, CA, United StatesReported Jun 25, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeModel Number
    53 affected lots
    CN932775ED11-202416933ED11-20249907ED11-202435949CN939348ED11-202417239ED11-202411745ED11-202436404
    +45 moreCN945176ED11-202419976ED11-202413957ED11-202437437CN946712ED11-202422121ED11-202414696ED11-202437710TEC29015668ED11-202422577ED11-202416838ED11-20243790829018601ED11-202428254ED11-202433998ED11-202449612RD10511988ED11-202428428ED11-2024351202420702905742ED11-20249819ED11-20243590920-607-UCHE-0006038-663465-0007433-16287-00223914-493GARIEPY-00048820-769300-00069720-663461ROBI-00070730-15958-0020067-804684-00198113-766227-0006336-662469CARM-00057620-15117-00134122-790909-0012738-489686-00044830-Y097-00214319-14364-00106110-788120-0012067-754951-0002063-RIEHL-001837CO19-2024-91576CO19-2024-68877CO19-2024-36953CO19-2024-24127

What the firm is doing

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 mgonzales@younginnovations.com

DistributionShow details

U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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