Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
FDA device recall Z-0153-2024 · posted 2023-10-24 · Open, Classified
Recall details
- Recalling firm
- Preat Corp
- Reason for recall
- The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- Action taken
- 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
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 23 units
- Distribution
- US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
- Date initiated
- 2023-07-18
- Date posted
- 2023-10-24
- Location
- Santa Maria, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Preat Abutments (K220823) | Preat Corporation | 2022-10-26 |