Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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.
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
Recall record
- Recalling firm
- Preat Corp
- Product type
- Devices
- Recall number
- Z-1987-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Santa Maria, CA
- Recall initiated
- 2025-04-02
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1987-2025 · Source: openFDA enforcement.