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
- Recall Number
- Z-1987-2025
- Event Number
- 96671
- Firm
- Preat Corp
- FEI Number
- 2918719
- Product Code
- NHA
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- April 2, 2025
- Posted
- June 18, 2025
- Address
- 2625 Skyway Dr, Ste B, Santa Maria, CA, 93455-1405
Description
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.
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.
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 [email protected]
U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
145 abutments