Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
FDA device recall Z-1285-2023 · posted 2023-03-24 · Open, Classified
Recall details
- Recalling firm
- Preat Corp
- Reason for recall
- Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
- Action taken
- On 2/21/23, recall notices were mailed to customers who were asked to discard or return affected devices to the recalling firm. In addition, in the event affected product was further distributed, customers were asked to inform their customers, or to provide a customer list so the recalling firm could notify these additional customers. The customer service number was provided: 800-232-7732
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 26
- Distribution
- US Nationwide distribution in the states of TX, OR, UT, NY.
- Date initiated
- 2023-02-21
- Date posted
- 2023-03-24
- Location
- Santa Maria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Preat Abutments (K220823) | Preat Corporation | 2022-10-26 |