Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
This recall is currently active, issued October 24, 2023. It was issued by Preat Corp.
- Company
- Preat Corp
- Recall Initiated
- July 18, 2023
- Posted
- October 24, 2023
- Recall Number
- Z-0153-2024
- Quantity
- 23 units
- Firm Location
- Santa Maria, CA
- Official Source
- View on FDA website ↗
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
Distribution
US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Lot / Code Info
UDI-DI: 00842092161388/Lot #OF018357
Root Cause
Process change control
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