FDA Medical Device Recalls (openFDA)
Preat Corp: NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
- Recall number
- Z-2514-2025
- Recalling firm
- Preat Corp
- Product
- NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
- Status
- Open, Classified
- Initiated
- 2025-06-25
- Posted
- 2025-09-03
- Terminated
- not on file
- Reason
- Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
- Root cause
- Process control
- Action
- On 06/25/2025, recall notices were mailed to customers who were asked to do the following: 1) Stop/cease use of the product in the scope of this recall 2) This product shall be discarded or returned to the recalling firm 2) All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be notified be provided a copy of this notification and informed to notify their customers. 3) Complete and return the Customer Response Form via email to mgonzales@younginnovations.com If you have any questions or concerns, please call/email the firm at: (800) 232-7732, mgonzales@younginnovations.com
- Quantity
- 11
- Distribution
- US Nationwide distribution in the states of NY, FL, PA, CA, OH.
- Lot, serial or model codes
- UDI-DI: 00842092169599. Lot: 277097
- 510(k) numbers
- ["K183518"]
- 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