Recall Z-0153-2024 ยท NHA Abutment, Implant, Dental, Endosseous
Preat Corp
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
| Date | Oct 24, 2023 (initiated Jul 18, 2023) |
| Status | Open, Classified |
| Reason | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage |
| Root cause | Process change control |
| Action | On August 4, 2023, Preat Corporation issued a "Urgent Medical Device Recall" notification via: USPS. Preat ask consignees to take the following actions: Product within the scope of the recall shall be discarded or returned to Preat Corporation. Instructions for the return will be provided. Complete and email response form to Nichole Fetterman, E-Mail: nfetterman@younginnovations.com or mail to Preat Corporation, Attn. Nichole Fetterman, 2625 Skyway Drive, Ste. B, Santa Maria, CA 93455 |
| Quantity | 23 units |
| Distribution | US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220823 | Preat Abutments Preat Corporation, Oct 26, 2022 |