Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in c
FDA device recall Z-1987-2025 · posted 2025-06-18 · Open, Classified
Recall details
- Recalling firm
- Preat Corp
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 145 abutments
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
- Date initiated
- 2025-04-02
- Date posted
- 2025-06-18
- Location
- Santa Maria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Preat Abutments (K183518) | Preat Corporation | 2019-03-18 |