Recall Z-1987-2025 ยท NHA Abutment, Implant, Dental, Endosseous
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.
| Date | Jun 18, 2025 (initiated Apr 2, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183518 | Preat Abutments Preat Corporation, Mar 18, 2019 |