FDA Medical Device Recalls (openFDA)
Preat Corp: Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Recall number
- Z-0153-2024
- Recalling firm
- Preat Corp
- Product
- Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Status
- Open, Classified
- Initiated
- 2023-07-18
- Posted
- 2023-10-24
- Terminated
- not on file
- 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
- Lot, serial or model codes
- UDI-DI: 00842092161388/Lot #OF018357
- 510(k) numbers
- ["K220823"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 2918719
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28