FDA Medical Device Recalls (openFDA)
Preat Corp: 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.
- Recall number
- Z-1987-2025
- Recalling firm
- Preat Corp
- 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.
- Status
- Open, Classified
- Initiated
- 2025-04-02
- Posted
- 2025-06-18
- Terminated
- not on file
- Reason
- 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
- 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 mgonzales@younginnovations.com
- Quantity
- 145 abutments
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K183518"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 2918719
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28