Recall Z-1321-2024 ยท NHA Abutment, Implant, Dental, Endosseous
Preat Corp
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
| Date | Mar 20, 2024 (initiated Feb 9, 2024) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant. |
| Root cause | Process change control |
| Action | On 02/09/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via US certified mail to customers to inform them that the abutment was manufactured with a dimensional condition that may lead to reduced engagement between the prosthetic screw and the implant. Customer are instructed to inspect their inventory and discard or return the affected products to PREAT CORPORATION. For questions or further assistance contact the Quality Assurance Manager at 800-232-7732 or email at nfetterman@younginnovations.com On 2/16/2024, the firm sent via certified USPS mail an "URGENT: MEDICAL DEVICE |
| Quantity | 561 units |
| Distribution | U.S. Nationwide distribution in the states of AZ, OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183518 | Preat Abutments Preat Corporation, Mar 18, 2019 |