Biomet 3i Certain-compatible 4 — Class II medical device recall Z-1987-2025
Ongoing recall by Preat Corp, reported 2025-06-25, distributed nationwide. Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may c
| Recall number | Z-1987-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preat Corp, Santa Maria, CA, United States |
| Recall initiated | 2025-04-02 |
| Classified | 2025-06-18 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 145 abutments |
| UPC / GTIN / UDI-DI | 00842092166093 |
| Lot numbers | 10-788120-001206, 13-766227-000633, 14-493GARIEPY-000488, 19-14364-001061, 20-15117-001341, 20-607-UCHE-000603, 20-663461ROBI-000707, 20-769300-000697, 22-790909-001273, 242070, 29018601, 2905742, 3-16287-002239, 3-RIEHL-001837, 30-15958-002006, 30-Y097-002143, 6-662469CARM-000576, 7-754951-000206, 7-804684-001981, 8-489686-000448, 8-663465-000743, CN932775, CN939348, CN945176, CN946712, CO19-2024-24127, CO19-2024-36953, CO19-2024-68877, CO19-2024-91576, ED11-202411745, ED11-202413957, ED11-202414696, ED11-202416838, ED11-202416933, ED11-202417239, ED11-202419976, ED11-202422121, ED11-202422577, ED11-202428254, ED11-202428428 and 13 more |
| Model numbers | 9001767-F |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1987-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.