Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
- Company
- Preat Corp
- Recall Initiated
- July 18, 2023
- Posted
- October 24, 2023
- Recall Number
- Z-0154-2024
- Quantity
- 4 units
- Firm Location
- Santa Maria, CA
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: 00842092161395/Lot #OF018355
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