FDA Medical Device Recalls (openFDA)
Preat Corp: 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
- Recall number
- Z-2318-2024
- Recalling firm
- Preat Corp
- Product
- 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
- Status
- Open, Classified
- Initiated
- 2024-04-10
- Posted
- 2024-07-08
- Terminated
- not on file
- Reason
- Due to incorrect milled titanium abutment being packaged and labeled.
- Root cause
- Process control
- Action
- On 05/21/2024, the firm sent via direct certified mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter to customers informing them that product labeled as part number 9006767-F Astra EV 4.8mm Milled Titanium Abutment may contain instead part number 9006667 Astra EV 4.2mm Milled Titanium Abutment. The potential risk identified was, the screw seat is higher than specified in the engineering drawings and required for full thread engagement with the implant. This condition reduces the screw thread engagement with the implant. Customer are instructed to: Product in the scope of this recall shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. 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. For questions or assistance contact Jose Espino at 224-622-7191 or email jespino@younginnovations.com
- Quantity
- 7 abutmens
- Distribution
- U.S.: CA, MO, and NV. O.U.S.: None
- Lot, serial or model codes
- Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
- 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