FDA Medical Device Recalls (openFDA)
Preat Corp: Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
- Recall number
- Z-1285-2023
- Recalling firm
- Preat Corp
- Product
- Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
- Status
- Open, Classified
- Initiated
- 2023-02-21
- Posted
- 2023-03-24
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process design
- Action
- 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
- Quantity
- 26
- Distribution
- US Nationwide distribution in the states of TX, OR, UT, NY.
- Lot, serial or model codes
- UDI: 00842092161326, Lots: 211891 and 211912
- 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